FDA List of Oral Appliances

Thornton
Adjustable Positioner (TAP)

The Thornton Adjustable Positioner uses the principle of cardiopulmonary resuscitation to keep the airway open in order to help patients maintain proper breathing techniques. Oxygen is allowed to flow adequately into the airway with the help of a device that holds the lower jaw forward to prevent collapse of the airway and eliminate instances of breathing cessation. With improved breathing, patients are able to get a good night’s rest and give
their partners a chance to sleep with decreased snoring. The TAP device is comfortable and adjustable to fit patients’ unique size and shape mouths.

SomnoMed MAS

The SomnoMed MAS is a custom-made device, consisting of upper and lower dental plates with a unique patented fin-coupling component, which allows normal mouth opening and closing. A patient adjustable feature provides incremental and adjustable levels of lower jaw advancement, which improves the effectiveness and comfort-level
of treatment as the jaw is moved only as far as is required to alleviate snoring and reduce OSA. Key features and benefits of the device include: Permits normal mouth opening, allows speech and drinking, provides full lip-seal, easily adjustable, safe and effective, clinically proven and custom-fitted. Additionally, the SomnoMed MAS is made from durable
fade-proof acrylic that retains its shape and color for at least four-five years and is covered by a two year manufacturer’s warranty.

The
SUAD™ Device:

The SUAD™ Device is a premium dental sleep appliance for the effective treatment of snoring and all levels of obstructive sleep apnea. It is safe, effective, and FDA cleared for treatment of OSA. The SUAD™ Device functions by slightly moving the lower jaw (mandible) in a comfortable, forward position to maintain an open airway. It is the only dental sleep appliance specifically engineered to withstand the forces of bruxism and its patented cast framework substructure helps minimize the potential of actual tooth movement.
The SUAD device is custom- made giving the patient an effortless, comfortable fit, without impinging on tongue space. It is also non-restrictive in movement allowing the
patient to fully open and close their mouth, speak clearly, yawn, and take oral medication while wearing the appliance. The SUAD™ Device is unlimited in
protrusive advancement and easily adjusted by adding additional nylon- type or metal advancement spacers. The SUAD™ Device is truly setting the standard in choices by being the only appliance that gives practitioners numerous design choice options including base material selection and choice of occlusal contact. Each SUAD™ Device fabricated comes with a two-year limited warranty on its metal components, including the framework, not just for manufacturer’s defects but also for accidental breakage by the patient.

The
Temporary SUAD™ Appliance (TSA):

The Temporary SUAD™ Appliance (TSA) is a temporary dental sleep appliance designed to mimic the functionality and performance of the renowned SUAD™ Device. The TSA is safe,effective, and FDA cleared to market for snoring and sleep apnea. It functions in the same manner as a premium appliance by comfortably positioning the lower jaw forward
to maintain an open airway. Unlike many other temporary appliances on the market, the TSA is not a boil-and-bite nor is it a chair-side fit appliance. Rather, the TSA is custom fabricated in our state-of-the-art laboratory using impressions of the patient’s teeth. The TSA requires minimal time for fabrication, making it an ideal real-time treatment option. The TSA serves many purposes including being a trial appliance for first-time patients seeking an affordable way to assess their compliance to oral appliance therapy. It also offers continuity of treatment for current appliance wearers should they happen to damage or lose their premium appliance. The compact size and convenience of the TSA makes it an
ideal back-up appliance for CPAP users as they no longer have to carry excess baggage or search for electrical outlets while travelling. The TSA also acts as a means of obtaining a bite registration when the patient decides to pursue treatment with a premium appliance.

Herbst
Telescopic
Appliance

The Herbst Appliance has been proven to be effective on chronic snoring and mild to moderate obstructive sleep apnea sufferers. This appliance allows patients to move laterally and vertically without disengaging the appliance. Also, if it is determined that the initial position does not provide the anticipated relief of the condition, the mandible can easily be moved forward by two options of adjustability. The first option is traditional hardware with sets of 1,2 and 3 mm shims for advancing those increments only. The second being the Telescopic version allowing the clinician to advance in ¼ mm increments by making one full turn of the protrusion collar up to 6-8mm from the start position. The appliance can be fabricated from hard acrylic, thermoactive and soft materials and is tooth retained via friction grip or clasps.
Tongue
Retaining Device (TRD)

The TRD is lab constructed of a flexible polyvinyl material adapted to the general contours of the teeth and dental arches. It does not depend on teeth for retention. Rather,
the tongue is held forward by the negative pressure created in the vacuum bulb on the front of the appliance.

SNOR-X

The SNOR-X is a mouth guard that gently holds the tongue forward during sleep, keeping the upper airway open and free from obstruction. The prevention of this
obstruction relieves snoring. SNOR-X is made of two pieces, a tongue sleeve and a plastic ring that goes around the device and is held in place by notches on each side of the sleeve.
The patient places their tongue into the tongue sleeve and squeezes the front end of the device to create a gentle suction that holds the tongue in an extended position. The patient can adjust the extension of the tongue for comfort and effectiveness. Air vents are sculpted onto the upper surface of the device to facilitate mouth breathing.

aveoTSD

Unlike oral dental devices , the aveoTSD does not attach to the teeth, and does not require specialist fitting by a dental professional. For maximum compliance this device
is best suited for use with consultation by a medical doctor or dental professional.The aveoTSD is a non-adjustable universal device that is the most cost effective and simple to use. Approved by the F.D.A in the U.S.A as a medical device.
Nose
Breathe Appliance

The Nose Breathe for Heavy Snorer
[NB/HS] is a NEW tongue-retaining
oral appliance. The tongue is held at the
roof of the mouth and retained by

a naturally occurring lip seal and tongue suction due to the negative

pressure of the oral cavity. It is an anatomical feature of the human oral cavity, only found during nasal
breathing. The breathing/swallowing/tongue placement mechanism must function
synergistically for normal esophageal peristalsis activity, as well
as for the normal cranio-facial
development. If not, problems, such as, acid reflux, aspiration, COPD, crooked teeth,
aerophagia, dysphagia, diabetes, asthma,
bed wetting,. could result. The biggest culprit
is the tongue activity during swallowing. Nasal breathing is the most effective
way to control the aberrant tongue
function. Nasal breathing/swallowing/tongue placement must be looked at as a unit and not as separate functions.

Clasp
Retained Mandibular Positioner

This appliance uses multiple clasps
to positively lock the mandible into the appliance and
prevent it from retruding. Because it is a one-piece appliance you can control the
vertical dimension by changing the height of the appliance. There is also a
larger airway cut into the acrylic in this design.

Elastomeric
Sleep Appliance

Constructed in a dental laboratory,
it is made of a very pliable soft, custom- injected silicone and is tooth retained. There
are no clasps or wires to

adjust. The flexibility of
the material lends
itself to a high degree of patient comfort. The Elastomeric appliance is not protrusively adjustable. The vertical
opening is 5 mm and the mandible is afforded some limited
movement
due to the high flexibility of the material.

OSAP

The OSAP is a full coverage mandibular
advancement mouthpiece made of a soft and flexible material
to ensure maximum
comfort
for the patient. The OSAP is custom made, with or without
an oral air passage, for optimal
effectiveness. The appliance is
compatible with home/office based bleaching techniques. A ready-made semi-universal trial version is also available for patients who
cannot endure having their impressions taken. In addition, the trial
version is an inexpensive way to test
a particular patients’ tolerance to oral therapy.
Works well with upper
edentulous and some full edentulous patients.

Sleep
Apnea Goldilocks Appliance (SAGA)

The SAGA incorporates the same materials and technology used to make Accutech’s Goldilocks splint,
which consists of a hard acrylic
shell laminated to a soft vinyl liner. The two arches are connected in the
posterior to hold the mandible in a protrusive and open position

Mandibular Inclined Repositioning Splint (MIRS)

An open airway is maintained
with this appliance by directly
holding the mandible in a downward
and toward position with
an incline flange. This flange is made
out of a thermoplastic material that softens at body temperature keeping it comfortable
for the patient. The body of the appliance is made
out of hard acrylic and snap fits to
the upper arch. The lower dentition is deeply
indexed into the occlusal surface of the appliance to hold the mandible
in the forward position. A breathing
hole is placed in the anterior
portion of the appliance to allow for easy breathing throughout the night.

Nocturnal
Airway Patency Appliance (NAPA)

The Nocturnal AIrway Patency Appliance (NAPA) is constructed in a

dental laboratory of rigid
acrylic and is tooth retained
by Adam’s clasps. An anterior
positioned “breathing beak: allows
for oral breathing when necessary. The
mandible is held firmly in position to prevent any jaw movement
during use and , thus, is non-adjustable. The vertical opening is

5 to 10mm.

SnoreFree

The SnoreFreeTM is a one-piece thermoplastic mandibular
repositioning appliance that is made
chairside. It comes
in a kit that contains everything from complete
instructions, to all the forms
necessary to screen your patients for snoring and apnea. When
you need an appliance to bring the tongue forward and clear the airway in the hypopharyngeal region, this
appliance is a good one to use first as it is
inexpensive, and it’s easy to use.

SnoreGuard

Snore Guard®, an oral appliance easily
assembled at chair side,
comprises a structure shaped to conform to
the upper dental arch of the user
and to create a ramp behind the lower anteriors. This ramp prevents the user’s jaw from receding; in addition,
the tongue seeks an opening between
the upper and lower portion of the
Snore Guard, thus keeping the air passage of the throat open.

SomnoGuard
2.0

One-part thermoplastic mandibular advancement device to treat snoring and mild to moderate obstructive sleep apnea. Appliance consists of a hypoallergenic thermoplastic body. After heating the appliance in water that has
been boiled the thermoplastic co-polymer becomes
soft and mouldable. While soft, the appliance is fitted to the upper and lower jaws and once cooled it is ready
to be worn at night. It differs from
the preceding SomnoGuard by a 3.0 mm thicker molar biting zone. This thicker molar area
means that fitting is faster and
easier for those patients with a “deep bite”.

Adjustable
PM Positioner

The Adjustable PM Positioner™
utilizes materials and a design that minimize office chair-time and provide the patient
control of adjusting the

jaw position under the dentist’s supervision. Research studies have
shown that this appliance is successful in treating
77% of patients with moderate obstructive sleep apnea.
The appliance fits over
all maxillary and mandibular teeth and is made of a special acrylic
material (BruxezeT) that softens in hot water to provide a combination
of comfort, strength, and retention. This
material has proven to be very durable. Expansion screws are located on
the right and left buccal areas to allow maximum
space for the tongue and easy anterior-posterior positioning of the mandible
to achieve optimal effectiveness.

This design permits ample
lateral and protrusive movement to maintain
jaw comfort.

The device uses a unique method of
retention consisting of small
projections of acrylic within the device that comfortably grip the undercut areas of two posterior teeth in each quadrant. Therefore, no metal clasps are
necessary.

APM
Ultra

The APM Ultra is the next generation
Adjustable PM Positioner. The APM Ultra has incorporated many design features
that will increase patient
comfort and acceptance in addition to effectiveness. The design features

include:

• Made
  of a comfortable heat-sensitive acrylic
• Retention
  by projections of acrylic (no clasps)
• Open
  in the anterior for easy breathing through the mouth (or nose)
• Excellent
  freedom of jaw movement (6 mm
  in lateral excursion)
• Smaller expansion
  screws on R and L buccal segments
  • Smaller overall
    size with shorter periphery and
    increased tongue space

Hilsen Adjustable Positioning Appliance

The appliance is constructed of maxillary
and mandibular full arch

thermoplastic
bases with Velcro-like attachments on the occlusal surfaces

of both. It is retained by friction grip to the teeth. These
provide simple and easy adjustment antero-posterior and left and right
over a wide range. Adjustments
are easily accomplished by the doctor
or patient.

Klearway Oral
Appliance

KlearwayT is a fully-adjustable oral appliance
used for the treatment of

snoring and mild
to moderate Obstructive Sleep Apnea. Fabricated of thermoactive
acrylic resin, Klearway becomes
pliable for easy insertion and confirms securely to the dentition for
an excellent fit while
significantly decreasing soft tissue and tooth discomfort. Small increments
(0.25mm) of forward lower jaw advancement are initiated by the patient under the
direction of a dentist and this helps
avoid rapid jaw movements that can cause significant
patient discomfort. The appliance does not encroach on tongue space. Once warmed under
hot water and inserted, the acrylic resin hardens as it cools to body temperature
and firmly affixes

itself to
both arches. Lateral
and vertical jaw movement
is permitted which enables the patient
to yawn, swallow, and drink water
without dislodging the appliance.

OASYS

The OASYS Oral/Nasal Airway SystemT is the first dental device to be reviewed by both the dental and ENT divisions of the FDA and to be approved as a dental device for
treatment of snoring and sleep apnea
through mandibular repositioning and
also as a nasal dilator for reduction of nasal resistance
and improved nasal breathing.

Silencer System

The Silencer? Professional is a laboratory
fabricated fully adjustable oral appliance for the treatment
of sleep apnea and snoring. The
appliance features a titanium precision
attachment, which controls the anatomical
settings of the appliance. It is capable of anteroposterior adjustment
as well as vertical adjustment
through a range of 10mm, in
both dimensions. The design of the
precision attachment also allows lateral movement of the mandible which respects and protects the
TMJ. The titanium Halstrom Hinge? is made of implant
grade titanium and carries a five-year warranty.

Elastic
Mandibular Advancement Appliance
(EMA)

The EM® – Custom appliance
is a simple, patient-friendly oral
appliance created for noninvasive treatment of snoring and OSA. The primary treatment mechanism
of opening the bite and gently moving the mandible
forward is achieved with the use of interchangeable elastic straps that offer
varying degrees of mandibular advancement.
The flexibility of these elastic
straps provides unsurpassed lateral movement
and overall TMJ comfort. The 2 mm thick pressure formed bases offer
orthodontic retention

(resulting in no tooth movement) and
maximum anterior
tongue space because there are no projections in the
palate.

Medical
Dental Sleep Appliance (MDSA)

MDSA Appliance Medical Dental Sleep Appliance (MDSA) A safe and effective treatment for snoring and mild to moderate sleep
apnea.

The
MDSA is

• Effective
• Comfortable
• Easy
  to keep clean
• Simple to use
• Australian
  designed and manufactured

NORAD Appliance

NORAD is an auto titratable, immediate placement,
mandibular repositioning device for
the management and treatment of snoring and sleep apnea. The
appliance, which is fabricated chairside, works by repositioning the lower jaw
downward and to a slightly more
forward position.

Silent
Nite

The Silent Nite® appliance
is prescribed by more dentists for
the initial treatment of snoring. Persons with mild sleep apnea also may be treated when surgical and other medical treatments are ineffective or not desired. A soft/hard frame material
is available for increased patient comfort.

Snore-Aid

Snore-Aid plus is an adjustable mandibular bite plate that advances the
mandible and repositions the tongue anteriorly and superiorly. The single plate
orthotic utilizes an external lip
shield and occlusal coverage to minimize
tooth pressures. It has no components that interfere with tongue posture
and vertical dimension can be altered at chairside. This appliance is
constructed from special thermoplastic
resins and vinyl polymers which make it comfortable,easy to fit
and very retentive. The external lip shield is easily titrated and can be quickly re-adjusted. The
single plate design enables the appliance
to be compatible with the patient’s
natural articular

pattern and condylar path and this renders it a suitable appliance for

nocturnal bruxers and TMD
sufferers. Description for
Web sites (public): Snore-Aid plus
is comfortable laboratory constructed
oral appliance that is prescribed by the dentist for snoring and mild
obstructive sleep apnea. The

appliance works
by advancing the mandible and positioning
the tongue to open the patient’s
airway, thus permitting easier
breathing and preventing loud snoring. Snore-Aid plus allows the patient to
have their natural jaw motions while they sleep so that their jaws do
not become sore from wearing the
appliance all night, every night.
This is particularly helpful in patients who grind their teeth (bruxism).
Speaking, yawning, and swallowing are not impaired by Snore-Aid plus. Dentists value how easily the appliance can be fitted
and adjusted. This durable appliance rarely
needs repair.

Z-appliance

The Z-appliance is a combination of a soft palate
lifter and a mandibular advancement device[the herbst].

TheraSnore Adjustable

The TheraSnore is one of the few appliances that requires no laboratory
construction and is easily fitted chairside from a boil and bite blank.

In the non-adjustable device the mandible is retained in a protrusive
position with pliable thermoplastic material
and is afforded limited movement.
Protrusive adjustability is possible
to a small degree.

SomnoGuard AP®

Two-part mandibular adjustable positioner with thermoplastic body to treat snoring and mild to moderate sleep
apnea.

SomnoGuard® AP is a unique mandibular advancement
device. Lateral movement of the jaw and an infinitely
adjustable protrusion are key features. SomnoGuard® AP consists of an upper and
a lower tray each made of two materials. The outer tray shells
consist of solid clear and transparent medical
grade polycarbonate. The inner lining which accommodates the teeth
impressions is made of a thermoplastic copolymer as
it is similarly used with the SomnoGuard® monobloc appliances. After the
oral appliance is heated in a hot
water bath its thermoplastic body
moulds easily to the teeth and jaws allowing
any medical doctor to fit the device
chair side.

SomnoGuard
AP Pro®

Dental lab made two-part mandibular
adjustable positioner
to treat snoring and mild to
moderate sleep apnea. The SomnoGuard® AP Pro can easily be constructed
from common acrylic/elastomeric thermoform dental
materials in any dental lab after taking impressions
of the lower and upper jaws and producing plaster models. The components used to connect the upper and lower
trays of the dental appliance and enable
the infinite advancement of the lower
jaw are made from stainless steel.
The components’ technology is based
on the preceding development of the SomnoGuard®
AP. The components are very durable, more or less indestructible, inexpensive
and can most often be reused when the
oral