1213Oral Appliances

2015-05-08

: Pdf 1213Oralappliances 1213OralAppliances 01 2014 sleeprev uploads wp-content

Open the PDF directly: View PDF .
Page Count: 5

22 • sleepreviewmag.com DECEMBER 2013

Company Advanced Brain

Monitoring Airway Management Inc Apnea Sciences Distar LLC Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Modern Dental

Laboratory USA

Product Name

Apnea Guard myTAP TAP ApneaRx Adjustable TheraSnore

OASYS Oral/Nasal Airway

System with Removable

CPAP Pro

aveoTSD Tongue

Stabilizing Device Silent Nite sl Herbst Appliance

MPowRx Snoring and

Sleep Apnea Appliance The Moses

Website www.advanced-sleep.com mytapappliance.com,

amisleep.com www.amisleep.com www.apnearx.com www.distar.com www.oasyssleep.com www.getaveo.com www.glidewelldental.com www.greatlakesortho.com www.greatlakesortho.com www.themoses.com

Warranty None 30-day satisfaction guarantee, 90-

day warranty

1 year parts and workmanship,

60-day patient satisfaction

guarantee

30-day guarantee with full

refund; 90-day replacement 1 year 1 year

6-month replacement warranty

from the date of purchase for

product defects determined to

be caused by the manufacturer

6 months if the failure is due to

defects in materials or

workmanship

90 day for metal component;

1 year for body material N/A 2 years

FDA 510(k) Clearance Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 2 years

INDICATIONS

Mild to

Moderate OSA X X X X X X X X

Severe OSA X

Snoring X X X X X X X X X X X

Bruxism X X X

Other Nasal Dilation, Tongue

Repositioning

TYPE

Custom

X X X X X

Noncustom

X X X X

Boil and Bite

X X X

How Does the Oral

Appliance Work?

Serves as inexpensive temporary

or titration appliance for up to 30

nights. Provides 1 mm increment

adjustments, three vertical sizes,

and predicted 70% advancement.

The myTAP advances and stabilizes

the mandible preventing the soft

tissues of the throat and tongue

from collapsing into the airway. It’s

based on the original TAP, which is

well validated in 30+ independent

peer review studies.

E0486 code verified by Medicare,

the TAP stabilizes the lower jaw in

the appropriate protrusive position,

preventing airway collapse and

tongue blockage while keeping

the jaw closed during sleep. The

TAP has a full range of adjustment

beyond maximum protrusion on

into maximum passive protrusion.

Advances the mandible in precisely

marked 1 mm increments.

Advances the mandible by

gently holding it in a protrusive

position. Patient has complete

vertical and lateral freedom of

movement and is not “locked”

into the appliance.

The device is adjustable and

repositions the mandible to

open the throat, with tongue

lifter buttons to train and posi-

tion the tongue forward. Nasal

Dilators improve breathing

through the nose.

The aveoTSD works by gently

suctioning onto the tip of the

tongue, preventing it from

falling back into the throat and

obstructing the airway.

Silent Nite sl works by positioning

the lower jaw forward using

special S-shaped connectors

that are attached to upper and

lower trays, which increases the

volumetric capacity of the airway.

It works by repositioning and

holding the mandible in a more

protrusive position, thereby

holding the tongue forward and

airway open.

It repositions the tongue forward

instead of relying on the alveolar

ridge or dentition to stay in

place. No impression needed.

The Moses incorporates all

three necessary attributes of

a successful therapy: tongue

management, mandibular

advancement, and patient

compliance.

Fitting Description

Fitted by patient with assistance

of a trained healthcare

professional within 15 minutes.

First, the lower tray is fitted

using predetermined amounts of

retention material, followed by

fitting of upper tray.

myTAP is in a category of its

own—“Precision Fit”—that allows

for accurate molding capabilities,

which eliminates the need for a bite

registration and lab fabrication. It’s

an immediate treatment solution.

When heated, the trays can be

widened or narrowed to fit any arch

size. It also features thin trays that

create a comfortable low profile

snoring appliance.

The TAP is fabricated in a licensed

dental laboratory and fitted by a

clinican. The upper and lower trays

are adjusted for retention and fit.

Initial protrusion is set during the

fitting process and can be easily

modified. Posterior stops may be

added for comfort if necessary.

Fitting takes less than 10 minutes.

Submerge in boiled water for 90

seconds. Dip into cup of tap water

for 3 seconds to cool off. Place in

patient’s mouth to custom-mold

for 30 seconds.

Custom fit in the doctor’s

office in less than 40 minutes.

Three different arch sizes

are available and 5 precise

adjustment settings available. A

heat-and-fit design customized

for each individual patient;

minimal trimming needed for

patient comfort.

The upper Biocryl Splint is

placed first. The lower Variflex

Splint is seated on the lower

teeth and the lips are pulled

over the Labial Shield and

Nasal Dilators.

Push the tongue gently into the

aveoTSD until it touches the

sides of the device. Squeeze the

bulb to draw the tongue into the

device until it is firmly attached.

It is custom thermoformed in

the laboratory from the patient’s

models. A bite registration taken

with the Slide-Link protrusion

gauge is used to determine

protrusive position and align

the device.

Very few adjustments are

required. The hard acrylic snaps

into place. When requested,

retention clasps can be added.

Comfortable, secure fit.

Maintains shape and one size

fits most.

The Moses is custom

fabricated in laboratory with

ISO 9001:2008 and ISO 13485

certifications. Use The Moses

Bite Shims for proper bite

registration and follow the video

instructions at www.themoses.

com/bite.

Adjustment

Description

Neutral, maximum, and

70% advancement, and bite

registration established with

Apnea Guard inserted. Optimal

jaw-forward positioning

established by titration study,

transferable to custom appliances

fabricated by a knowledgeable

dental lab.

myTAP is a midline advancement oral

appliance that is unique to all TAP

designs. The adjustment mechanism is

attached to the lower tray and threaded

through the adjustment post of the

upper tray. A dial is screwed onto the

end of the threaded adjustment mech-

anism allowing the patient to control

the treatment position. With its incre-

mental advancement (1/3 mm per half

turn) capabilities and its wide range of

adjustment (20 mm total), the myTAP

incorporates Airway Management Inc’s

existing custom technology.

Adjustment may be made by the

patient with the TAP in the mouth.

An anterior dial with one point

of adjustment prevents unequal

torque. The clinician teaches a

home titration schedule, which

engages the patient in the therapy

process. The TAP may also be eas-

ily adjusted in the sleep lab by the

sleep tech during a study.

Simple patent-pending adjustment

mechanism is unaided by external

accessories (screws, bands, etc).

Provides marked 1 mm adjustment

and locking capability with a 10

mm range.

Easily adjusted by separating

two halves of the appliance

and following the number

guide along the side to the

appropriate protrusion setting.

Appliance snaps into place with

desired setting via a locking

mechanism.

The anterior shield is on a

sliding/locking system, with

mm guides. Pushing on shield

increases protrusion. The

Nasal and Tongue Buttons are

adjusted with pliers and/or

finger pressure.

The device requires no

adjustment. Small, medium,

and large sizes are available.

For patients with longer than

average tongues, 4 mm/7 mm

Uni-Spacers can be clipped onto

the device for extra titration.

Slide-Link connectors attach

to the upper and lower trays.

These connectors come in five

lengths (21-25 mm) and are

easily interchangeable by the

patient if the lower jaw needs

repositioning.

0.25 mm adjustment with

telescopic hardware, or 1 mm

using advancement shims with

the standard hardware option.

Non-custom, non-adjustable.

The jaw relationship established

by the bite registration will be

the exact jaw position of the

fabricated Moses. Titrate The

Moses by activating the bilateral

expansion screw mechanisms

with the key provided. Eight

turns = 1.0 mm.

Materials

Biocompatible plastic trays that

adjust and accommodate a full

range of arch widths. Protrusive

ranges are lined with heavy-set

polyvinyl siloxane retention

material customized to the

patient’s teeth.

The myTAP is an all-plastic design.

The trays are made from a plastic

that when heated becomes soft and

can be molded to the teeth at the

time of fitting. If reheated, the trays

will return to their original shape and

can be refitted.

Hardware material is surgical grade

stainless steel. The trays have two

hard layers of a durable polymer and

the inner lining is one of two types

designated by the clinician. Triple

Laminate is the most popular, using

DuraSoft, which enables retention

by comfortably gripping the teeth.

ThermAcryl is the other option, which

softens when heated to allow “snap-

ping” and reshaping for patients who

have dental work.

Soft thermal plastic and hard

acrylic.

Soft thermal plastic and hard

acrylic.

Upper 1.5 mm Biocryl

retainer/splint; lower Variflex

thermoplastic splint, with

Biocryl ice shield, onlays, and

buttons; stainless steel wire

with welded corners for sliding

bars; Duraloy wire for nasal

dilators and tongue buttons;

stainless steel locks.

The aveoTSD is made of 0.4

mm thick soft medical-grade

silicone.

The upper tray of the Silent Nite

sl is made of a soft polyurethane

inner layer and a hard copolyes-

ter outer layer that are BPA-free.

Depending on retention, the

lower tray is made from this

same dual-layered material or all

hard copolyester.

Standard hard acrylic but can

be made of Veriflex, a thermal-

reactive option.

Thermoplastic elastomer Hard acrylic and Essix C+ upper

retainer

Recommended

Cleaning and

Maintenance

Clean daily by rinsing with cold

water and a soft toothbrush.

With regular toothbrush and cool

water

After use, clean with a

toothbrush, cool water, and

antibacterial soap. The TAP can

be soaked weekly in a diluted

peroxide solution for 5 minutes.

Clean daily with soft toothbrush

and toothpaste.

Brush appliance after each use

to remove any debris; clean

every 2 days using OrthoFresh

cold water cleaner.

Brush gently with soft tooth-

brush and antibacterial soap/

mild toothpaste. Use nonal-

cohol denture cleaner for 15

minutes.

The aveoTSD should be rinsed

under hot water daily and

washed thoroughly once a

week using a denture cleaning

solution.

Rinse well with water before and

after use and store dry. Clean

appliance with soap and warm

water only.

Use of DentaSOAK is

recommended along with

toothbrush and toothpaste daily.

Must be stored dry.

Use of DentaSOAK is

recommended along with

toothbrush and toothpaste daily.

Must be stored dry.

Use a denture cleaner, such as

3-minute Polident, and clean

daily.

Published, Peer-reviewed

Validation Articles Yes No Yes No Yes Yes Yes No Yes Yes Yes

Information for this guide based on data submitted by product manufacturers. Sleep Review

strives for accuracy in all data but cannot be held responsible for claims made by manufacturers.

oRal applianCEs

DECEMBER 2013 sleepreviewmag.com • 23

Company Advanced Brain

Monitoring Airway Management Inc Apnea Sciences Distar LLC Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Modern Dental

Laboratory USA

Product Name

Apnea Guard myTAP TAP ApneaRx Adjustable TheraSnore

OASYS Oral/Nasal Airway

System with Removable

CPAP Pro

aveoTSD Tongue

Stabilizing Device Silent Nite sl Herbst Appliance

MPowRx Snoring and

Sleep Apnea Appliance The Moses

Website www.advanced-sleep.com mytapappliance.com,

amisleep.com www.amisleep.com www.apnearx.com www.distar.com www.oasyssleep.com www.getaveo.com www.glidewelldental.com www.greatlakesortho.com www.greatlakesortho.com www.themoses.com

Warranty None 30-day satisfaction guarantee, 90-

day warranty

1 year parts and workmanship,

60-day patient satisfaction

guarantee

30-day guarantee with full

refund; 90-day replacement 1 year 1 year

6-month replacement warranty

from the date of purchase for

product defects determined to

be caused by the manufacturer

6 months if the failure is due to

defects in materials or

workmanship

90 day for metal component;

1 year for body material N/A 2 years

FDA 510(k) Clearance Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 2 years

INDICATIONS

Mild to

Moderate OSA X X X X X X X X

Severe OSA X

Snoring X X X X X X X X X X X

Bruxism X X X

Other Nasal Dilation, Tongue

Repositioning

TYPE

Custom

X X X X X

Noncustom

X X X X

Boil and Bite

X X X

How Does the Oral

Appliance Work?

Serves as inexpensive temporary

or titration appliance for up to 30

nights. Provides 1 mm increment

adjustments, three vertical sizes,

and predicted 70% advancement.

The myTAP advances and stabilizes

the mandible preventing the soft

tissues of the throat and tongue

from collapsing into the airway. It’s

based on the original TAP, which is

well validated in 30+ independent

peer review studies.

E0486 code verified by Medicare,

the TAP stabilizes the lower jaw in

the appropriate protrusive position,

preventing airway collapse and

tongue blockage while keeping

the jaw closed during sleep. The

TAP has a full range of adjustment

beyond maximum protrusion on

into maximum passive protrusion.

Advances the mandible in precisely

marked 1 mm increments.

Advances the mandible by

gently holding it in a protrusive

position. Patient has complete

vertical and lateral freedom of

movement and is not “locked”

into the appliance.

The device is adjustable and

repositions the mandible to

open the throat, with tongue

lifter buttons to train and posi-

tion the tongue forward. Nasal

Dilators improve breathing

through the nose.

The aveoTSD works by gently

suctioning onto the tip of the

tongue, preventing it from

falling back into the throat and

obstructing the airway.

Silent Nite sl works by positioning

the lower jaw forward using

special S-shaped connectors

that are attached to upper and

lower trays, which increases the

volumetric capacity of the airway.

It works by repositioning and

holding the mandible in a more

protrusive position, thereby

holding the tongue forward and

airway open.

It repositions the tongue forward

instead of relying on the alveolar

ridge or dentition to stay in

place. No impression needed.

The Moses incorporates all

three necessary attributes of

a successful therapy: tongue

management, mandibular

advancement, and patient

compliance.

Fitting Description

Fitted by patient with assistance

of a trained healthcare

professional within 15 minutes.

First, the lower tray is fitted

using predetermined amounts of

retention material, followed by

fitting of upper tray.

myTAP is in a category of its

own—“Precision Fit”—that allows

for accurate molding capabilities,

which eliminates the need for a bite

registration and lab fabrication. It’s

an immediate treatment solution.

When heated, the trays can be

widened or narrowed to fit any arch

size. It also features thin trays that

create a comfortable low profile

snoring appliance.

The TAP is fabricated in a licensed

dental laboratory and fitted by a

clinican. The upper and lower trays

are adjusted for retention and fit.

Initial protrusion is set during the

fitting process and can be easily

modified. Posterior stops may be

added for comfort if necessary.

Fitting takes less than 10 minutes.

Submerge in boiled water for 90

seconds. Dip into cup of tap water

for 3 seconds to cool off. Place in

patient’s mouth to custom-mold

for 30 seconds.

Custom fit in the doctor’s

office in less than 40 minutes.

Three different arch sizes

are available and 5 precise

adjustment settings available. A

heat-and-fit design customized

for each individual patient;

minimal trimming needed for

patient comfort.

The upper Biocryl Splint is

placed first. The lower Variflex

Splint is seated on the lower

teeth and the lips are pulled

over the Labial Shield and

Nasal Dilators.

Push the tongue gently into the

aveoTSD until it touches the

sides of the device. Squeeze the

bulb to draw the tongue into the

device until it is firmly attached.

It is custom thermoformed in

the laboratory from the patient’s

models. A bite registration taken

with the Slide-Link protrusion

gauge is used to determine

protrusive position and align

the device.

Very few adjustments are

required. The hard acrylic snaps

into place. When requested,

retention clasps can be added.

Comfortable, secure fit.

Maintains shape and one size

fits most.

The Moses is custom

fabricated in laboratory with

ISO 9001:2008 and ISO 13485

certifications. Use The Moses

Bite Shims for proper bite

registration and follow the video

instructions at www.themoses.

com/bite.

Adjustment

Description

Neutral, maximum, and

70% advancement, and bite

registration established with

Apnea Guard inserted. Optimal

jaw-forward positioning

established by titration study,

transferable to custom appliances

fabricated by a knowledgeable

dental lab.

myTAP is a midline advancement oral

appliance that is unique to all TAP

designs. The adjustment mechanism is

attached to the lower tray and threaded

through the adjustment post of the

upper tray. A dial is screwed onto the

end of the threaded adjustment mech-

anism allowing the patient to control

the treatment position. With its incre-

mental advancement (1/3 mm per half

turn) capabilities and its wide range of

adjustment (20 mm total), the myTAP

incorporates Airway Management Inc’s

existing custom technology.

Adjustment may be made by the

patient with the TAP in the mouth.

An anterior dial with one point

of adjustment prevents unequal

torque. The clinician teaches a

home titration schedule, which

engages the patient in the therapy

process. The TAP may also be eas-

ily adjusted in the sleep lab by the

sleep tech during a study.

Simple patent-pending adjustment

mechanism is unaided by external

accessories (screws, bands, etc).

Provides marked 1 mm adjustment

and locking capability with a 10

mm range.

Easily adjusted by separating

two halves of the appliance

and following the number

guide along the side to the

appropriate protrusion setting.

Appliance snaps into place with

desired setting via a locking

mechanism.

The anterior shield is on a

sliding/locking system, with

mm guides. Pushing on shield

increases protrusion. The

Nasal and Tongue Buttons are

adjusted with pliers and/or

finger pressure.

The device requires no

adjustment. Small, medium,

and large sizes are available.

For patients with longer than

average tongues, 4 mm/7 mm

Uni-Spacers can be clipped onto

the device for extra titration.

Slide-Link connectors attach

to the upper and lower trays.

These connectors come in five

lengths (21-25 mm) and are

easily interchangeable by the

patient if the lower jaw needs

repositioning.

0.25 mm adjustment with

telescopic hardware, or 1 mm

using advancement shims with

the standard hardware option.

Non-custom, non-adjustable.

The jaw relationship established

by the bite registration will be

the exact jaw position of the

fabricated Moses. Titrate The

Moses by activating the bilateral

expansion screw mechanisms

with the key provided. Eight

turns = 1.0 mm.

Materials

Biocompatible plastic trays that

adjust and accommodate a full

range of arch widths. Protrusive

ranges are lined with heavy-set

polyvinyl siloxane retention

material customized to the

patient’s teeth.

The myTAP is an all-plastic design.

The trays are made from a plastic

that when heated becomes soft and

can be molded to the teeth at the

time of fitting. If reheated, the trays

will return to their original shape and

can be refitted.

Hardware material is surgical grade

stainless steel. The trays have two

hard layers of a durable polymer and

the inner lining is one of two types

designated by the clinician. Triple

Laminate is the most popular, using

DuraSoft, which enables retention

by comfortably gripping the teeth.

ThermAcryl is the other option, which

softens when heated to allow “snap-

ping” and reshaping for patients who

have dental work.

Soft thermal plastic and hard

acrylic.

Soft thermal plastic and hard

acrylic.

Upper 1.5 mm Biocryl

retainer/splint; lower Variflex

thermoplastic splint, with

Biocryl ice shield, onlays, and

buttons; stainless steel wire

with welded corners for sliding

bars; Duraloy wire for nasal

dilators and tongue buttons;

stainless steel locks.

The aveoTSD is made of 0.4

mm thick soft medical-grade

silicone.

The upper tray of the Silent Nite

sl is made of a soft polyurethane

inner layer and a hard copolyes-

ter outer layer that are BPA-free.

Depending on retention, the

lower tray is made from this

same dual-layered material or all

hard copolyester.

Standard hard acrylic but can

be made of Veriflex, a thermal-

reactive option.

Thermoplastic elastomer Hard acrylic and Essix C+ upper

retainer

Recommended

Cleaning and

Maintenance

Clean daily by rinsing with cold

water and a soft toothbrush.

With regular toothbrush and cool

water

After use, clean with a

toothbrush, cool water, and

antibacterial soap. The TAP can

be soaked weekly in a diluted

peroxide solution for 5 minutes.

Clean daily with soft toothbrush

and toothpaste.

Brush appliance after each use

to remove any debris; clean

every 2 days using OrthoFresh

cold water cleaner.

Brush gently with soft tooth-

brush and antibacterial soap/

mild toothpaste. Use nonal-

cohol denture cleaner for 15

minutes.

The aveoTSD should be rinsed

under hot water daily and

washed thoroughly once a

week using a denture cleaning

solution.

Rinse well with water before and

after use and store dry. Clean

appliance with soap and warm

water only.

Use of DentaSOAK is

recommended along with

toothbrush and toothpaste daily.

Must be stored dry.

Use of DentaSOAK is

recommended along with

toothbrush and toothpaste daily.

Must be stored dry.

Use a denture cleaner, such as

3-minute Polident, and clean

daily.

Published, Peer-reviewed

Validation Articles Yes No Yes No Yes Yes Yes No Yes Yes Yes

24 • sleepreviewmag.com DECEMBER 2013

Company Myerson ResMed SML – Space Maintainers Laboratories SML – Space Maintainers

Laboratories SomnoMed Strong Dental

Product Name

Myerson EMA Narval CC Adjustable Dorsal Full Breath Solution Lamberg Sleep Well ZQuiet Pro-Plus SomnoDent Flex SomnoDent G2 The Standard SUAD Device

The SUE 2G

(Second Generation)

The SUAD B-H

(Basic Herbst)

Website www.myersontooth.com www.resmed.com/narval smlsleep.com smlsleep.com smlsleep.com smlsleep.com www.somnomed.com www.somnomed.com www.strongdental.com www.strongdental.com www.strongdental.com

Warranty n/a 3 years 1 year (materials and

workmanship)

1 year (material and

workmanship)

1 year (materials and

workmanship)

1 year (material and

workmanship) 3 years 3 years 5-year limited 5-year limited 2-year limited

FDA 510(k) Clearance Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X X

Severe OSA

Snoring X X X X X X X X X X X

Bruxism X X X

Other

TYPE

Custom

X X X X X X X X X X X

Noncustom

Boil and Bite

How Does the Oral

Appliance Work?

EMA uses interchangeable

elastic straps and posterior bite

pads attached to thermoformed

custom trays to allow gradual

advancement of the mandible

and increased vertical opening

until treatment is successful.

Narval CC is the first and only com-

puter-aided design/computer-aided

manufacturing (CAD/CAM) appliance

on the market; patented articulation

along the occlusal plane maintains

lower jaw in a forward position

promoting physiological breathing

during sleep.

Uses precision-milled upper and

lower occlusal appliances to

open the vertical relationship,

with buccal “dorsal” fins to

hold the mandible forward and

allows for the desirable degree of

lateral movement. Suitable for all

dentitions.

Lower single-arch appliance with

proprioceptive tongue control with

no mandibular advancement

This appliance advances the

mandible in .5 mm increments

and opens the vertical in 3 mm

increments. The lower jaw has

freedom of movement along

the arc of opening/closing.

Consists of two custom acrylic

orthotics (one for the maxillary arch

and one for the mandibular), a buccal

cam mechanism (apposing fin and

buttress) that maintains the orthotics

in the proper AP relationship. Upon

request, the maxillary orthotic can

be made with an Omega Loop for

patients who suffer from frequent

headaches due to appliance use.

The SomnoDent Flex, made

with proprietary SMH BFlex, is a

premium comfort, patient specific

device worn during sleep to treat

mild to moderate sleep apnea.

The SomnoDent G2 is an

easy to calibrate, standard

metal-free customized

device worn during sleep to

treat mild to moderate sleep

apnea.

The Standard SUAD stabilizes

the lower jaw in the required

protrusive position to effectively

treat snoring and OSA.

The SUE 2G stabilizes the lower

jaw in the required protrusive

position to effectively treat snoring

and OSA. The design of the SUE

2G allows for an increase in

tongue space and airflow volume.

The SUAD B-H stabilizes the

lower jaw in the required

protrusive position to effectively

treat snoring and OSA.

Fitting Description

Fit the upper and lower ap-

pliances without the elastic

straps to check for comfort

and to make sure there is no

gingival impingement. Check

the posterior bite pads for even

occlusion.

Narval CC uses CAD technology to

suit the complex dental anatomy

of individual patients; does not

load incisors and the innate lateral

flexibility eliminates “locked-in”

sensation, patients can easily talk

and drink.

It is only necessary to verify that

the upper and lower appliances

seat fully and the vertical and AP

position is correct. Patient should

wear the appliance for several

days, after which time mandible

advancement is performed via

Adjustment Key if necessary

(expansion screws on upper

portion of the appliance).

Chair side fitting similar to fitting

a bruxism splint. If patient is

comfortable with appliance,

schedule recall in 1 week. If

patient experiences a gag reflex

and/or swallowing inhibition,

“tail” will have to be modified. If

problem persists, trans-lingual bar

must be “arched up.”

Appliance does not require

special fitting at delivery visit.

It is only necessary to verify

that the upper and lower

members seat fully.

Seat appliance and check for

patient comfort

SomnoDent Flex comprises

upper and lower dental trays

with a patented fin-coupling

component, allowing normal

mouth opening and closing.

SomnoDent G2 comprises

upper and lower dental trays

with a patented fin-coupling

component, allowing normal

mouth opening and closing.

The SUAD Device is manufactured

exclusively by Strong Dental and

delivered by the dentist. After

placing appliance in warm tap

water for approximately 1 minute,

the appliance is inserted onto the

patient’s dentition and checked

for fit and proper occlusal contact.

Adjustments made if necessary.

Optional occlusal contacts are

available.

The SUE 2G is manufactured

exclusively by Strong Dental

and delivered by the dentist.

Its occlusal surface mimics

the Morning Repositioner (bite

deprogrammer), reducing the

likelihood of jaw discomfort.

The SUAD B-H is manufactured

exclusively by Strong Dental

and delivered by the dentist.

After placing appliance in warm

tap water for approximately

1 minute, the appliance is

inserted onto the patient’s

dentition and checked for fit.

Adjustment

Description

The EMA appliance uses

four different strengths of

elastic straps in nine different

lengths to gradually titrate

the mandible. The shorter or

stronger the strap, the further

the mandible is advanced.

Narval CC is easy to titrate

and highly adjustable with

connecting rods that allow for

15 mm of protrusive range at

1 mm increments. The dentist/

patient can simply select a shorter

connecting rod until optimal

advancement is achieved.

The appliance has two jack

screws built in—one on each

side. They must both be adjusted

together for anterior movement.

Each turn of the expansion screw

from bar to bar advances the

mandible approximately one-

quarter millimeter (.25 mm).

Appliance may be modified with

adding acrylic to the “tail”

A series of “inserts” slide

into the upper appliance

to increase the amount of

mandibular protrusion (up to

9 mm) in .5 mm increments.

Vertical adjustment can also

be achieved with a vertical

“insert.”

It is adjustable in .25 mm

increments (by patient or doctor). A

total of 6 mm of anterior movement

is possible.

The SomnoDent Flex achieves

mandibular advancement by

means of bilateral adjustment

screws located on the upper

maxillary splint. As the screw

mechanisms are titrated,

they engage with the wings

or fins on the lower splint to

advance the mandible. The

adjustment mechanism allows

the mandibular protrusion to be

adjusted in the range of -0.5

mm to +5.5 mm from the preset

level for a total of 6 mm.

Provides patients with an easy

to use modular adjustment

system, which allows instant

and accurate measurement.

The device has a small coupling

mechanism, is slim-line and

more posteriorly located. The

adjustment clips allow the

mandibular protrusion to be

adjusted in the range of -2.0

mm to +8.0 mm from the preset

level for a total of 10 mm.

Unique tube and rod mecha-

nism, virtually unlimited in

protrusive advancement.

Standard Herbst arms advanced

using friction fit or metal spac-

ers. Telescopic Herbst arms

are available and advanced

using key.

Unique tube and rod

mechanism, virtually unlimited

in protrusive advancement.

Same arm options as SUAD

Device and SUAD B-H. Vertical

adjustment can be realized by

building discluding elements

with acrylic.

Unique tube and rod

mechanism, virtually unlimited

in protrusive advancement.

Standard Herbst arms advanced

using friction fit or metal

spacers. Telescopic Herbst arms

are available and advanced

using key.

Materials

The EMA appliance is

completely metal free. The

custom trays are made from a

proprietary thermoplastic and

the straps from a latex-free

polymer.

Narval CC is made of a

highly resilient and durable

biocompatible polymer material

and then manufactured through

selective laser sintering to allow

the device to be strong yet supple

as well as flexible yet highly

resilient. Narval is metal-free,

flexible, and lightweight.

Available in Dual Laminate, All

Acrylic, and Thermoplastic (Talon)

Available in Dual Laminate, All

Acrylic, and Thermoplastic (Talon)

Hard polycarbonate and hard

acrylic

Available in Dual Laminate, All

Acrylic, and Thermoplastic (Talon)

SMH BFlex, a soft polymer

that is heat-cured, packed, and

pressed utilizing a chemical

formula that facilitates soft to

hard polymer bonding at the

layers. Surgical grade stainless

steel adjustment mechanism.

Soft Liner: Made from SMH

BFlex, a soft polymer that

is heat-cured, packed, and

pressed utilizing an exclusive

chemical formula that facilitates

soft to hard polymer bonding

at the layers. Ball Clasps:

Made from the highest quality

acrylic that will not discolor.

Both options feature durable

polycarbonate adjustment

winglets and clips.

Choice of base material

(softer dual laminate or firmer

solid thermoflex). Choice of

advancement arms. All metal

components are made with 300

series medical grade stainless

steel.

To reduce the bulk of the

appliance and allow more

tongue space, all SUE 2Gs

are fabricated out of solid

thermoflex material. All metal

components are made with 300

series medical grade stainless

steel and the casted framework

is made using chromium cobalt.

Choice of base material

(softer dual laminate or firmer

solid thermoflex). Choice of

advancement arms. All metal

components are made with 300

series medical grade stainless

steel.

Recommended Cleaning

and Maintenance

Clean appliance in tepid water

with a toothbrush and toothpaste

or soak it in a denture cleaning

solution; no mouthwash.

Clean Narval CC daily in lukewarm

water with a soft brush and a mild

soap/baking soda. Rinse, dry,

and store in case provided. Twice

weekly, use the Sonic Cleaner

provided with an effervescent

antibacterial tablet.

Use OAP Dental Appliance

Cleaner, which is an anti-fungal,

anti-viral, anti-bacterial, and

anti-germicide.Simply spray,

brush, and rinse—a 1-minute

procedure.

Use OAP Dental Appliance

Cleaner, which is an anti-fungal,

anti-viral, anti-bacterial, and anti-

germicide.Simply spray, brush,

and rinse—a 1-minute procedure.

Use OAP Dental Appliance

Cleaner, which is an anti-fun-

gal, anti-viral, anti-bacterial,

and anti-germicide.Simply

spray, brush, and rinse—a

1-minute procedure.

Use OAP Dental Appliance

Cleaner, which is an anti-fungal,

anti-viral, anti-bacterial, and anti-

germicide.Simply spray, brush, and

rinse–a 1-minute procedure.

Rinse daily in cold or lukewarm

water and clean with a soft

toothbrush and a mild detergent,

such as liquid soap. Always

store in a container of clean

water when not in use.

Rinse daily in cold or lukewarm

water and clean with a soft

toothbrush and a mild detergent,

such as liquid soap. Always

store in a container of clean

water when not in use.

Brush daily, after use, with a

soft toothbrush and toothpaste.

Soak daily in Polident solution

(partial retainer 3 minutes or 5

minutes).

Brush daily, after use, with a

soft toothbrush and toothpaste.

Soak daily in Polident solution

(partial retainer 3 minutes or 5

minutes).

Brush daily, after use, with a

soft toothbrush and toothpaste.

Soak daily in Polident solution

(partial retainer 3 minutes or 5

minutes).

Published, Peer-reviewed

Validation Articles Yes Yes No No No No Yes Yes No No No

Information for this guide based on data submitted by product manufacturers. Sleep Review

strives for accuracy in all data but cannot be held responsible for claims made by manufacturers.

oRal applianCEs

DECEMBER 2013 sleepreviewmag.com • 25

Company Myerson ResMed SML – Space Maintainers Laboratories SML – Space Maintainers

Laboratories SomnoMed Strong Dental

Product Name

Myerson EMA Narval CC Adjustable Dorsal Full Breath Solution Lamberg Sleep Well ZQuiet Pro-Plus SomnoDent Flex SomnoDent G2 The Standard SUAD Device

The SUE 2G

(Second Generation)

The SUAD B-H

(Basic Herbst)

Website www.myersontooth.com www.resmed.com/narval smlsleep.com smlsleep.com smlsleep.com smlsleep.com www.somnomed.com www.somnomed.com www.strongdental.com www.strongdental.com www.strongdental.com

Warranty n/a 3 years 1 year (materials and

workmanship)

1 year (material and

workmanship)

1 year (materials and

workmanship)

1 year (material and

workmanship) 3 years 3 years 5-year limited 5-year limited 2-year limited

FDA 510(k) Clearance Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X X

Severe OSA

Snoring X X X X X X X X X X X

Bruxism X X X

Other

TYPE

Custom

X X X X X X X X X X X

Noncustom

Boil and Bite

How Does the Oral

Appliance Work?

EMA uses interchangeable

elastic straps and posterior bite

pads attached to thermoformed

custom trays to allow gradual

advancement of the mandible

and increased vertical opening

until treatment is successful.

Narval CC is the first and only com-

puter-aided design/computer-aided

manufacturing (CAD/CAM) appliance

on the market; patented articulation

along the occlusal plane maintains

lower jaw in a forward position

promoting physiological breathing

during sleep.

Uses precision-milled upper and

lower occlusal appliances to

open the vertical relationship,

with buccal “dorsal” fins to

hold the mandible forward and

allows for the desirable degree of

lateral movement. Suitable for all

dentitions.

Lower single-arch appliance with

proprioceptive tongue control with

no mandibular advancement

This appliance advances the

mandible in .5 mm increments

and opens the vertical in 3 mm

increments. The lower jaw has

freedom of movement along

the arc of opening/closing.

Consists of two custom acrylic

orthotics (one for the maxillary arch

and one for the mandibular), a buccal

cam mechanism (apposing fin and

buttress) that maintains the orthotics

in the proper AP relationship. Upon

request, the maxillary orthotic can

be made with an Omega Loop for

patients who suffer from frequent

headaches due to appliance use.

The SomnoDent Flex, made

with proprietary SMH BFlex, is a

premium comfort, patient specific

device worn during sleep to treat

mild to moderate sleep apnea.

The SomnoDent G2 is an

easy to calibrate, standard

metal-free customized

device worn during sleep to

treat mild to moderate sleep

apnea.

The Standard SUAD stabilizes

the lower jaw in the required

protrusive position to effectively

treat snoring and OSA.

The SUE 2G stabilizes the lower

jaw in the required protrusive

position to effectively treat snoring

and OSA. The design of the SUE

2G allows for an increase in

tongue space and airflow volume.

The SUAD B-H stabilizes the

lower jaw in the required

protrusive position to effectively

treat snoring and OSA.

Fitting Description

Fit the upper and lower ap-

pliances without the elastic

straps to check for comfort

and to make sure there is no

gingival impingement. Check

the posterior bite pads for even

occlusion.

Narval CC uses CAD technology to

suit the complex dental anatomy

of individual patients; does not

load incisors and the innate lateral

flexibility eliminates “locked-in”

sensation, patients can easily talk

and drink.

It is only necessary to verify that

the upper and lower appliances

seat fully and the vertical and AP

position is correct. Patient should

wear the appliance for several

days, after which time mandible

advancement is performed via

Adjustment Key if necessary

(expansion screws on upper

portion of the appliance).

Chair side fitting similar to fitting

a bruxism splint. If patient is

comfortable with appliance,

schedule recall in 1 week. If

patient experiences a gag reflex

and/or swallowing inhibition,

“tail” will have to be modified. If

problem persists, trans-lingual bar

must be “arched up.”

Appliance does not require

special fitting at delivery visit.

It is only necessary to verify

that the upper and lower

members seat fully.

Seat appliance and check for

patient comfort

SomnoDent Flex comprises

upper and lower dental trays

with a patented fin-coupling

component, allowing normal

mouth opening and closing.

SomnoDent G2 comprises

upper and lower dental trays

with a patented fin-coupling

component, allowing normal

mouth opening and closing.

The SUAD Device is manufactured

exclusively by Strong Dental and

delivered by the dentist. After

placing appliance in warm tap

water for approximately 1 minute,

the appliance is inserted onto the

patient’s dentition and checked

for fit and proper occlusal contact.

Adjustments made if necessary.

Optional occlusal contacts are

available.

The SUE 2G is manufactured

exclusively by Strong Dental

and delivered by the dentist.

Its occlusal surface mimics

the Morning Repositioner (bite

deprogrammer), reducing the

likelihood of jaw discomfort.

The SUAD B-H is manufactured

exclusively by Strong Dental

and delivered by the dentist.

After placing appliance in warm

tap water for approximately

1 minute, the appliance is

inserted onto the patient’s

dentition and checked for fit.

Adjustment

Description

The EMA appliance uses

four different strengths of

elastic straps in nine different

lengths to gradually titrate

the mandible. The shorter or

stronger the strap, the further

the mandible is advanced.

Narval CC is easy to titrate

and highly adjustable with

connecting rods that allow for

15 mm of protrusive range at

1 mm increments. The dentist/

patient can simply select a shorter

connecting rod until optimal

advancement is achieved.

The appliance has two jack

screws built in—one on each

side. They must both be adjusted

together for anterior movement.

Each turn of the expansion screw

from bar to bar advances the

mandible approximately one-

quarter millimeter (.25 mm).

Appliance may be modified with

adding acrylic to the “tail”

A series of “inserts” slide

into the upper appliance

to increase the amount of

mandibular protrusion (up to

9 mm) in .5 mm increments.

Vertical adjustment can also

be achieved with a vertical

“insert.”

It is adjustable in .25 mm

increments (by patient or doctor). A

total of 6 mm of anterior movement

is possible.

The SomnoDent Flex achieves

mandibular advancement by

means of bilateral adjustment

screws located on the upper

maxillary splint. As the screw

mechanisms are titrated,

they engage with the wings

or fins on the lower splint to

advance the mandible. The

adjustment mechanism allows

the mandibular protrusion to be

adjusted in the range of -0.5

mm to +5.5 mm from the preset

level for a total of 6 mm.

Provides patients with an easy

to use modular adjustment

system, which allows instant

and accurate measurement.

The device has a small coupling

mechanism, is slim-line and

1213Oral Appliances

Navigation menu

Versions of this User Manual:

Views

Navigation