Types of

Appliances

Currently, over 100 different types of dental devices for snoring and sleep apnea are available to specially trained dentists to treat sleep disordered breathing including primary snoring and obstructive sleep apnea. At first glance, this number appears overwhelming but on close examination each of the appliances falls basically into one of two categories and the diverse variety is simply a variation of a few major themes. Oral appliances can be classified by mode of action or design variation.

If you are a laboratory, inventor or manufacturer and your appliance is not listed here, please contact us directly at info@snoringisntsexy.com.

Oral Appliances

FDA Approval Date:

02/08/1996

FDA Approval Number:

K955503

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Yes

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 (Bruxeze) 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. Clinical Research Associates gave the Adjustable PM Positioner its highest rating for appliances tested. 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, and Smaller overall size with shorter periphery and increased tongue space.

FDA Approval Date:

FDA Approval Number:

FDA Approved For:

Medicare Approved:

DNA Appliance

The DNA appliance harness pain-free, natural, epigenetic developmental mechanisms that aim to correct tooth alignment, improve facial development, ameliorate TMD issues and enhance the upper airway without using surgery, drugs or injections. The extended acrylic based or wire frame DNA appliance is primarily designed to correct midfacial and or maxillary underdevelopment in adults diagnosed with sleep disordered breathing. In some respects it represents a new generation of tongue restraining appliances, which may be used in conjunction with CPAP therapy, initially. It is preferably worn during the evenings (but not during eating) and at night time to allow the appliance to provide its optimal benefits over a 12-16 hour cycle of the human growth hormone circadian rhythm.

FDA Approval Date:

03/31/2011

FDA Approval Number:

03/31/2011

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Yes

Dorsal

Originally designed as a nighttime TMD splint, the Dorsal Appliance has evolved into one of the most popular choices for snoring and obstructive sleep apnea. The two piece construction allows for patient comfort and lateral jaw movement. The Dorsal fins on the mandibular appliance interface with inclines built into the buccal of the upper appliance to dictate a specific mandibular position. The appliance is traditionally fabricated with adjustable screws in the maxillary appliance to allow for further mandibular advancement. This appliance can be fabricated in a variety of materials including acrylic, dual laminate or thermal splint material.

DreamTAP appliance

FDA Approval Date:

n/a

FDA Approval Number:

K062951

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

DreamTAP

The ultra-comfortable dreamTAP appliance is designed with hardware on its exterior, offering greater tongue space with no obstructions.With more tongue space, patients experience greater comfort and a healthier sleep. Its single point of midline adjustment prevents uneven bilateral adjustment that may create an irregular bite and jaw discomfort. Stronger than surgical stainless steel, the hardware is made from nickel-free cobalt-chromium, removing the risk of an allergic reaction. DreamTAP comes in three hook sizes for greater range of adjustment, is corrosion resistant, and utilizes custom-formed soft liners for superior retention.

Adjustment mechanism advances the mandible 0.25mm with each turn of the key. Patients can vary the position precisely by counting the turns. This allows both the dentist and the patient to confidently maintain the proper treatment position and yet allows them to make changes depending on the patient's symptoms.

FDA Approval Date:

09/29/1997

FDA Approval Number:

K971794

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Elastic Mandibular Advancement Appliance (EMA)

The EMA® - 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. The Elastic Mandibular Advancement (EMA®) appliance uses elastic force to advance the mandible. Hand plastic trays are pressure formed to the patient''s models and utilize the undercut areas of the teeth for retention. This insures that there will be no movement of the patient''s teeth. Bite planes are used to open the bite. Mandibular advancement is achieved with different length straps. The elastic pull can also be adjusted to suit the patient''s musculature. The straps provide complete lateral movement. The EMA® - Custom is available only to dental professionals.

FDA Approval Date:

12/29/2005

FDA Approval Number:

K052862

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

FullBreath Appliance

The design of the Full Breath Solution focuses on inhibition of tongue movement; inhibiting the rise and backward movement of the tongue so that it does not block the airway during sleep. With a single arch appliance designed to provide subtle yet effective admustments, the Full Breath Solution imporves airflow 100% of the time and stops snoring with 95% of all patients.

FDA Approval Date:

03/29/1996

FDA Approval Number:

K955822

FDA Approved For:

Snoring

Medicare Approved:

Yes

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. The Herbst Appliance is a mandibular repositioner that has been in use many years for orthodontic and TMJ therapy prior to its modification for treatment of sleep disordered breathing. The greatest advantage of the Herbst appliance is that it allows for very quick, easy and accurate mandibular protrusive adjustability. This is accomplished through simple manipulation of the rod/sleeve plunger mechanism. Vertical opening varies is 5 mm and there is limited freedom of movement for the mandible in a lateral direction. Bilateral interarch elastics are recommended to keep the jaw closed during sleep. NOTE: Some clinicians feel that limited lateral movement of the lower jaw during appliance use is beneficial for TMJ comfort while others believe it is of no benefit. Also, some clinicians find compromised effectiveness if the mandible is allowed to drop down even as much as a millimeter during appliance use while others find no difference. These are both areas that require more scientific study. We are presently unaware of the precise effect of these parameters on appliance effectiveness.

FDA Approval Date:

02/13/2019

FDA Approval Number:

K182661

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Kava

Kava Dorsal is the first appliance to utilize a unique mandibular advancement dorsal screw. Engineered by Apex for a sleek, refined, effective design, the Kava Dorsal creators kept the patient in mind at every step.

  • Reduced thickness for increased comfort
  • Reinforced material for added strength
  • Simplified activation for error-proof advancement
  • 0.1mm advancement with a 6mm range
  • Minimal profile for increased comfort and reduced bulk

FDA Approval Date:

05/24/1995

FDA Approval Number:

K950763

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Klearway Appliance

Klearway™ is a fully-adjustable oral appliance used for the treatment or snoring and mild to moderate Obstructive Sleep Apnea. Fabricated of thermoactive acrylic, KlearwayTM 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 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. 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 patent to yawn, swallow, and drink water without dislodging the appliance.

FDA Approval Date:

12/14/2006

FDA Approval Number:

K062333

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

LSWD-Lamberg Sleep Well

The LSWD is a mandibular advancement device. It is inserted in the mouth and fits on the palate like a retainer. It has a protrusive element (PE) which rests behind the lower anterior teeth to maintain them in a comfortable forward position. This allows the lower jaw to move freely from side to side as well as open slightly. The appliance will be dispensed with a suck down for lower anteriors which can be used as necessary. The protrusive element will extend downward approximately 10mm and thus prevent the lower teeth from disengaging it. Most unique is the feature that there is an anterior stop (no material on the posterior teeth) which serves to minimize clenching. Since clenching is a necessary component of bruxing, it will reduce bruxing as well. The patent is pending and it is FDA accepted for snoring.

FDA Approval Date:

06/22/2010

FDA Approval Number:

K101709

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Lamberg Sleep Well

The LambergSleepWell-Smartrusion (LSW-S) appliance is built around patient comfort and ease of use. The design of this appliance allows for unparalleled movement of the lower jaw. Movement side to side and opening and closing are virtually unrestricted with the Lamberg appliance. No longer is it necessary to have both jaws tethered together with uncomfortable bulky hardware. It is arguably the most comfortable appliance. Patients wear it every night and hardly notice it in. It is also the appliance of choice for "tooth grinders" and "clenchers" as it reduces muscle activity more than other appliances. Overall, simple to clean, simple to maintain, and simple to wear. It may be just what you were looking for.

FDA Approval Date:

05/12/2010

FDA Approval Number:

K093710

FDA Approved For:

For Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Moses

The Moses appliance is a two-piece device that allows patients to talk, drink, open wide and close their lips, making this one of the most comfortable appliances available. It stimulates protrusive tongue reflexes while an open anterior design advances the tongue and enlarges the cross-sectional area of the airway. The flexible upper retainer (in green) helps prevent tooth movement and acts as an anchor for the entire maxillary arch. Attached to the base, the blue section determines how far the mandible is pushed forward. Advantages include: Elevates tongue to the hard palate and increases nasal air flow, Allows lip seal, Corrects dysphagia (difficulty swallowing), comfortable and adjustable.

FDA Approval Date:

09/23/2016

FDA Approval Number:

K161832

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

O2Vent

Introducing an innovative approach to oral appliance therapy – a treatment platform featuring Oventus Airway Technology. Oventus Airway Technology is designed to allow continued airflow to the oropharynx in the presence of nasal or soft palate obstruction. If device breathing is required during sleep, an oral seal is maintained and ventilation normalizes. With a unique, low resistance airway incorporated into its patented design, the O2Vent™ customized oral appliances deliver air to the back of the mouth, allowing for breathing through the appliance, by passing nasal resistance and velopharyngeal obstruction. The “T” device connects at the front before you insert into your mouth. You can titrate your lower jaw forward to a comfortable range that further opens your airway.

FDA Approval Date:

08/26/2003

FDA Approval Number:

K030440

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

OASYS

The OASYS Oral/Nasal Airway System 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. The OASYS Oral/Nasal Airway System functions to: Act as a mandibular repositioner, act as a nasal dilator, and allow mouth breathing to occur, if required. The OASYS Oral/Nasal Airway System is designed to achieve these functions with the following goals: Maintain maximize the intraoral volume; Minimize the force on the teeth; Have no components that extend extra orally through the lips.; To reduce upper airway resistance. THE OASYS ORAL/NASAL AIRWAY SYSTEM REDUCES THE FORCES ON THE TEETH BY DESIGN. The OASYS Oral/Nasal Airway System fits securely onto the lower arch only. The upper flange extends in front of the upper arch and under the upper lip. This maintains a slippage during mandibular movements during usage. There is a nature give to the wires that creates a yielding give when the mandible pulls back on the device. Provided is an upper splint that distributes the forces through the entire arch. Together these act to reduce the forces on the teeth. The OASYS Oral/Nasal Airway System maintains maximal tongue space by positioning the connectors and adjustment components outside of the dental arch leaving the palate and anterior oral space completely free for the tongue to position itself up and forward. There is usually even an open space for the tip of the tongue to go between the incisor teeth. The OASYS Oral/Nasal Airway System maintains the patentcy of the oropharyngeal airway by functioning as a mandibular repositioner and as a nasal dilator by maintaining a stretch in the nasal labial tissue to dilate the internal nares.For more information visit http://www.oasyssleep.com.

FDA Approval Date:

03/08/2013

FDA Approval Number:

K121285

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Oravan™

Oravan™ is an FDA cleared, patented, custom-fit, dorsal fin appliance for the treatment of snoring and OSA with a true open anterior design. It’s the only device on the market that has no anterior or incisal coverage on the top and bottom teeth, encouraging natural protrusion of the tongue and incredible patient comfort. Further, the appliance will not interfere with any anterior dental cosmetic work, promoting less clinical chair time required at the fitting session. Oravan™ is composed of two separate top and bottom clear acrylic pieces that allows patients the freedom to open and close their mouth and lips, speak clearly, yawn, drink, and most of all…smile with the look and feel of their own teeth.

FDA Approval Date:

10/28/2015

FDA Approval Number:

K152159

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Yes

Oravan™ Herbst

Similar to the Oravan™, the Oravan™ Herbst contains a truly open anterior design, encouraging natural protrusion of the tongue, maximum patient comfort, and less clinical chair time at the fitting session. The telescopic arms connecting the upper and lower components allow for easy lateral and vertical movement, which is particularly beneficial for those patients that brux or grind their teeth while sleeping. This appliance is also Medicare PDAC APPROVED.

FDA Approval Date:

12/15/2014

FDA Approval Number:

K143244

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Panthera D-SAD

Created by Panthera, D-SAD(digital sleep apnea device) is a custom-made anti-snoring mouth guard tailor-made for the customer by a dentist for ultimate comfort.
The device has been designed to maintain the lower jaw in a forward position. The advancement of the jaw increases the diameter of the airway, thus improving the airflow so one can breathe clearly.

D-SAD is flexible and minimizes bulk in the mouth when sleeping due to its small size and comfort. The major technology behind this device is the fact that the system transfers forces in the horizontal plane (no other anti-snoring device does this). It reduces muscle pain and stress on the temporomandibular joints. Since the retaining rods and the pivot points located on the triangles of the lower retainer and on the anchor points of the upper retainer are elevated, vertical forces are suppressed. The fact that there are no vertical forces limits the retention of the retainers to strong teeth, which increases comfort and, consequently, improves patient compliance to the treatment. The device works in the same direction than the muscles and the design.

FDA Approval Date:

06/24/2014

FDA Approval Number:

K133683

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

Prosomnus

The Prosomnus features a sleek, one-piece design that is easy to adjust. The low profile design, contoured cheek borders, and extra space for your tongue make durable oral appliance very comfortable to wear while sleeping. The Prosomnus does not require patients to manage any mechanical adjustments, such as turning screws or changing positions with elastics. Instead, the Prosomnus comes with one pair of upper and lower arches set to the prescription and a second pair set in any amount of advancement increments. Advancements are easily achieved by simply removing the current upper or lower arch device and inserting the next advancement device in the Prosomnus series. The Prosomnus is milled with CAD/CAM technology for a precise, comfortable fit.

FDA Approval Date:

08/23/2011

FDA Approval Number:

K111207

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Respire

The Respire Blue Series is a custom made oral sleep device. It is composed of an upper and a lower component, which are not connected in any way, allowing the jaw to open and close naturally. The dorsal fin holds the jaw in a forward position preventing it from falling back and the airway collapsing. The Respire also has an anterior opening which allows the patient to breathe through their mouth, in turn providing extra patient comfort. The advancement screw enables the doctor or patient to protrude the jaw at ? mm increments at a time, with a total advancement of 5.5 mm from the starting position. This device can be made with an acrylic fitting surface or a soft dual-laminate material.

FDA Approval Date:

10/30/1995

FDA Approval Number:

K954530

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Silencer

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(r) is made of implant grade titanium and carries a five-year warranty. There are three component materials in the Silencer. The body of the appliance is constructed of elastamer,a pliable material which offers the patient a much greater degree of comfort than harder acrylic materials. For additional support, to the dentition as well as the temporomandibular joint, hard acrylic bite pads are placed in the molar regions. A commercially pure titanium articulating component grants the appliance the many adjustment characteristics that make the Silencer unique - kind to the tissues, the teeth, and the temporomandibular joint.

FDA Approval Date:

09/18/1997

FDA Approval Number:

K972424

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

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.

Somnodent Classic appliance

FDA Approval Date:

06/18/2015

FDA Approval Number:

K150369

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Somnodent Classic

The SomnoDent Classic is SomnoMed’s original innovation in customized oral devices, the Classic is held in place using medical grade stainless steel ball clasps. Offers drop-in fit and comes in a version that allows for more space for the patient’s tongue. 91% of patients reported improvement in sleep quality with SomnoDent.

Other SomnoDent appliance versions include: DentiTracMicro-Recorder, SomnoDent Flex with DentiTrac Micro-Recorder, SomnoDent HerbstAdvance (Classic or Flex Retention) With DentiTrac Micro-Recorder, SomnoDent G2 (Classic Or Flex Retention) With DentiTrac Micro-Recorder, SomnoDent Fusion (Classic Or Flex Retention) Wit.

Somnodent Suad appliance

FDA Approval Date:

07/08/2003

FDA Approval Number:

K023836

FDA Approved For:

ObstructiveSleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

Somnodent Suad

The Somnodent SUAD, formerly the SUAD Elite, features a casted frame that traces the arches, creating strength.  The modified Herbst design allows for lateral movement and easy titration. Mesh component added to the labial surface – complete arch is totally encapsulated by casted substructure to ensure that the dentition will not move. Non-restrictive in movement, it allows patients to fully open and close their mouth, drink water, speak clearly, yawn, and take medication while wearing their appliance. Unlimited protrusive advancement does not have fins that limit lateral movement and does not lock the upper and lower jaw together.

FDA Approval Date:

08/21/1997

FDA Approval Number:

K972061

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

TAP

The Thornton Adjustable Positioner® (TAP®) is a simple, patient-friendly treatment solution for snoring and sleep apnea. The TAP holds the lower jaw in a forward position so that it does not fall open during the night and cause the airway to collapse. It maintains a clear airway to reduce snoring and improve breathing. The unique design allows the patient to fine-tune his/her treatment at home and work with the clinician to achieve the best results. Patients are empowered to manage the degree of lower jaw protrusion over as many nights as it takes to achieve the optimal treatment position. The TAP has a single point of central adjustment, which prevents uneven bilateral adjustment that can create an irregular bite and discomfort. The TAP has over a 95% success rate. It is the key to a snore-free, restful night of sleep. The TAP also treats sleep apnea without the need for surgery, a mask, or medication. The TAP is recognized as the market leader in oral appliances for snoring and sleep apnea and is currently prescribed by over 7,000 dentists worldwide to treat snoring and sleep apnea. In addition, it is the most researched oral appliances on the market with over 30 independent peer reviewed published studies. A simple dental examination is necessary to know if the patient will be able to use an oral appliance.

FDA Approval Date:

12/12/2014

FDA Approval Number:

K140663

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

TheraSnore

The TheraSnore is one of the few appliances that requires no laboratory construction and is easily fitted chairside from a boil and bite. 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. In the adjustable TheraSnore, patients are started at centric relation. Should it be necessary to protrude the mandible, it can be done in precise 1.5 mm increments without refitting the appliance. The Adjustable TheraSnore is also available in 3 different arch sizes based on the most commonly used impression trays. This has been very important to TheraSnore patients who have a smaller or larger than average arch size. The TheraSnore also allows the mandible complete vertical and lateral freedom of movement to ensure the problems associated with TMJ/TMD are thereby avoided and the patient is comfortable.

FDA Approval Date:

12/31/1999

FDA Approval Number:

n/a

FDA Approved For:

Obstructive Sleep Apnea (OSA) and Snoring

Medicare Approved:

n/a

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. The appliance is available in four tongue extensions and with or without air way tubes for patients with compromised airway patency. It is constructed in conjunction with the Kel Gauge (described in another section of this program.) Since the mandible is not rigidly or firmly held by the appliance, freedom of movement is possible during use. This would seem to make the TRD a good choice for the edentulous patient, the patient with periodontal disease and the patient with temporomandibular joint dysfunction.There is ample research available documenting the effectiveness for treatment of snoring and OSA in certain patients. NOTE: Mandibular repositioners have been successfully used in edentulous patients over dentures in certain cases where the dentures have had adequate retention. Mandibular repositioners have also been successfully used in patients with compromised periodontal status or TMJ function. In these cases, however, the clinician needs to be especially careful in design and follow up.

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