1213Oral Appliances

2015-05-08

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Advanced Brain
Monitoring

Airway Management Inc

Apnea Sciences

Distar LLC

Product Name

Apnea Guard

myTAP

TAP

ApneaRx

Adjustable TheraSnore

Website

www.advanced-sleep.com

mytapappliance.com,
amisleep.com

www.amisleep.com

www.apnearx.com

www.distar.com

Warranty

None

30-day satisfaction guarantee, 90day warranty

1 year parts and workmanship,
60-day patient satisfaction
guarantee

30-day guarantee with full
refund; 90-day replacement

1 year

FDA 510(k) Clearance
Mild to
Moderate OSA
Severe OSA
Snoring
Bruxism

Yes

X
X

INDICATIONS

oral appliances

Company

Other
TYPE

Custom

Noncustom
Boil and Bite

Serves as inexpensive temporary
or titration appliance for up to 30
nights. Provides 1 mm increment
adjustments, three vertical sizes,
and predicted 70% advancement.

E0486 code verified by Medicare,
The myTAP advances and stabilizes the TAP stabilizes the lower jaw in
the mandible preventing the soft
the appropriate protrusive position,
tissues of the throat and tongue
preventing airway collapse and
from collapsing into the airway. It’s
tongue blockage while keeping
based on the original TAP, which is the jaw closed during sleep. The
well validated in 30+ independent TAP has a full range of adjustment
peer review studies.
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.

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.

Adjustment
Description

myTAP is a midline advancement oral
appliance that is unique to all TAP
designs. The adjustment mechanism is Adjustment may be made by the
Neutral, maximum, and
attached to the lower tray and threaded patient with the TAP in the mouth.
70% advancement, and bite
An anterior dial with one point
through the adjustment post of the
registration established with
of adjustment prevents unequal
upper tray. A dial is screwed onto the
Apnea Guard inserted. Optimal
torque. The clinician teaches a
end of the threaded adjustment mechjaw-forward positioning
anism allowing the patient to control
home titration schedule, which
established by titration study,
the treatment position. With its incre- engages the patient in the therapy
transferable to custom appliances
mental advancement (1/3 mm per half process. The TAP may also be easfabricated by a knowledgeable
turn) capabilities and its wide range of ily adjusted in the sleep lab by the
dental lab.
sleep tech during a study.
adjustment (20 mm total), the myTAP
incorporates Airway Management Inc’s
existing custom technology.

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.

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 “snapping” and reshaping for patients who
have dental work.

Soft thermal plastic and hard
acrylic.

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.

How Does the Oral
Appliance Work?

Materials

Recommended
Cleaning and
Maintenance

Biocompatible plastic trays that The myTAP is an all-plastic design.
adjust and accommodate a full
The trays are made from a plastic
range of arch widths. Protrusive that when heated becomes soft and
ranges are lined with heavy-set
can be molded to the teeth at the
polyvinyl siloxane retention
time of fitting. If reheated, the trays
material customized to the
will return to their original shape and
patient’s teeth.
can be refitted.

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.

Yes

Published, Peer-reviewed
Validation Articles

22 • sleepreviewmag.com

DECEMBER 2013

Dream Systems LLC

Glidewell Laboratories

Modern Dental
Laboratory USA

Great Lakes Orthodontics Ltd

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

www.oasyssleep.com

www.getaveo.com

www.glidewelldental.com

www.greatlakesortho.com

www.themoses.com

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

Yes

2 years

X
X

X
X
X
X
Nasal Dilation, Tongue
Repositioning

X
X

The device is adjustable and
repositions the mandible to
open the throat, with tongue
lifter buttons to train and position 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.

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.

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.

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.

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.

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.

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.

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 copolyester 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 thermalreactive option.

Thermoplastic elastomer

Hard acrylic and Essix C+ upper
retainer

Brush gently with soft toothbrush and antibacterial soap/
mild toothpaste. Use nonalcohol 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 a denture cleaner, such as
3-minute Polident, and clean
daily.

Yes

DECEMBER 2013

It works by repositioning and
holding the mandible in a more
protrusive position, thereby
holding the tongue forward and
airway open.

Very few adjustments are
required. The hard acrylic snaps
into place. When requested,
retention clasps can be added.

sleepreviewmag.com • 23

Myerson

Website

SML – Space Maintainers Laboratories

Myerson EMA

Narval CC

Adjustable Dorsal

Full Breath Solution

www.myersontooth.com

www.resmed.com/narval

smlsleep.com

Lamberg Sleep Well
smlsleep.com

1 year (material and
workmanship)

1 year (materials and
workmanship)

Warranty

n/a

3 years

1 year (materials and
workmanship)

FDA 510(k) Clearance
Mild to
Moderate OSA
Severe OSA
Snoring
Bruxism
Other
Custom
Noncustom
Boil and Bite

Yes

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 computer-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.

Fitting Description

Fit the upper and lower appliances 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.

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 onequarter 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.”

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)

Hard polycarbonate and hard
acrylic

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 antigermicide. 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.

Published, Peer-reviewed
Validation Articles

Yes

TYPE
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.

ResMed

Product Name

INDICATIONS

oral appliances

Company

24 • sleepreviewmag.com

DECEMBER 2013

SML – Space Maintainers
Laboratories

SomnoMed

Strong Dental

ZQuiet Pro-Plus

SomnoDent Flex

SomnoDent G2

The Standard SUAD Device

The SUE 2G
(Second Generation)

The SUAD B-H
(Basic Herbst)

smlsleep.com

www.somnomed.com

www.strongdental.com

1 year (material and
workmanship)

3 years

5-year limited

2-year limited

Yes

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.

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.

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 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.

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.

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.

Use OAP Dental Appliance
Cleaner, which is an anti-fungal,
anti-viral, anti-bacterial, and antigermicide. 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.

Brush daily, after use, with a
soft toothbrush and toothpaste.
Soak daily in Polident solution
(partial retainer 3 minutes or 5
minutes).

Yes

DECEMBER 2013

sleepreviewmag.com • 25

Tomed Dr. Toussaint GmbH

Product Name

SomnoGuard AP
Website

SomnoGuard SP Soft

www.tomedcare.com

1 year against manufacturer’s defects

1 year against manufacturer’s
defects

Yes

How Does the Oral
Appliance Work?

The 2-part SomnoGuard AP
repositions the lower jaw forward
and thereby prevents the collapse of
the upper airway. With the device in
place, the upper airway is wider and
the patient can breathe more easily
without snoring.

The 2-part SomnoGuard SP Soft
repositions the lower jaw forward
and thereby prevents the collapse of
the upper airway. With the device in
place, the upper airway is wider and
the patient can breathe more easily
without snoring.

Fitting Description

Fitting can be done by doctors or
their trained staff in approximately
15 minutes. No special accessories
needed apart from a boiling water
bath, a small pair of scissors, and
gripping tongs.

Adjustment
Description

The lower jaw can be infinitely
repositioned forward (titration) by
any degree up to about 10 mm by
an adjusting screw inserted into the
screw guide of the lower jaw tray.
Adjustments are quickly and easily
made outside of the mouth. Protrusion
changes can be done by doctors or
the instructed patients themselves.

Two connectors of equal length
combine laterally the upper and lower
jaw trays and enable the advancement
of the lower jaw from approximately
-3 mm to +10 mm. This type of
mandibular positioner also can be
worn by retrognathic bite patients.
Adjustments are quickly and easily
made outside of the mouth. Protrusion
changes can be done by doctors or the
instructed patients themselves.

Materials

Rigid polycarbonate (rigid tray walls),
soft thermal copolymer (lining), stainless steel adjusting screws

Rigid polycarbonate (rigid tray walls),
soft thermal copolymer (lining), semirigid plastic (connectors)

Recommended Cleaning
and Maintenance

Clean daily with soft toothbrush and
mild liquid soap or a liquid denture
cleaner. Rinse and let the device dry
in the open air.

Published, Peer-reviewed
Validation Articles

Yes

Warranty
FDA 510(k) Clearance
INDICATIONS

oral appliances

Company

Mild to
Moderate OSA
Severe OSA
Snoring
Bruxism
Other

TYPE

Custom
Noncustom

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.

Boil and Bite

26 • sleepreviewmag.com

DECEMBER 2013

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1213Oral Appliances

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