CPAP/PRO is a nasal pillow device that is held in place by custom or boil and bite appliance. It may also attach to a mandibular repositioning appliance.FDA Approval: Approved for both snoring and OSA
Date of FDA Approval: Dec. 1, 1999
FDA Registration Number: K992384

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: Approved for both Snoring and OSA
Date of FDA Approval: Sept. 29, 1997
FDA Registration Number: K971794

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.Proven effective by the University of Kentucky Medical Center Sleep Apnea Laboratory. Recommended for partially edentulous patients and non-bruxers.FDA Approval: Approved for both snoring and OSA
Date of FDA Approval: June 14, 1995
FDA Registration Number: K946112

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.

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: Approved for treatment of snoring
Date of FDA Approval: March 1996
FDA Registration Number: K955822

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.
FDA Approval: Approved for both Snoring and OSA
Date of FDA Approval: October 21, 1997
FDA Registration Number: K963591

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 510 (k) for snoring. K062333
Trade Name Lamberg Sleep Well Device
Regulation Numberg: 872.5570
Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK
Dated: December 7, 2006
Received: December 7, 2006

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.FDA Approval:
Date of FDA Approval:
FDA Registration Number:

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

The MDSA is

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

The Medical Dental Sleep Appliance (MDSA) has been developed in direct consultation with leading Australian dentists, sleep physicians and dental technicians.

It is a titratable mandibular advancement appliance with these special added features:

• Ability to adjust the advancement when the appliance is in place using a key
• Lateral movement of the mandible with the appliance in place reduces TMJ problems and improves comfort
• Low profile of the appliance allows minimum opening of the bite.

The laboratory made MDSA holds the jaw and tongue forward and prevents the throat from collapsing during sleep.

The results of a study at the Austin and Repatriation Medical Centre Sleep Clinic, a crossover trial comparing the MDSA, nasal CPAP and placebo confirm that this is a safe and effective treatment for snoring and mild to moderate sleep apnoea. Patient compliance and comfort was significantly greater with the MDSA than the CPAP. The MDSA is scientifically proven as an effective method for treating snoring and mild to moderate sleep apnoea.

The MDSA is an alternative therapy when other treatments that involve nasal CPAP or surgery are not accepted.

The O.R.M.(r) type Device is a new generation custom-made mandibular repositioning  device with patented physiological articulation and unique comfortable splints to optimize patient acceptance and treatment efficacy.  It is recognised by many specialists as the most discrete and comfortable mandibular advancement device available and thousands of patients recognize the benefits of this simple to use yet extremely efficient therapeutic solution.

In March 2009, Narval launched the O.R.M.(r) mandibular repositioning device using the Narval CADCAM Technology (Computer Aided-Design and Computer Aided Manufacturing) by laser sintering a polymer powder.   The CADCAM Technology offers more customization possibilities for the device and a greater mechanical strength.

Simplicity

• You can put it in and out and out your mouth in a few seconds
• You will get accustomed to the device on the first couple of nights;
• You may talk discernibly or drink a glass of water while wearing your O.R.M.(r) device;
  You can take it easily anywhere you go.

Clinical success : results on 108 patients with OSAS and obstructive snoring (1)

• Efficacy of more than 80% in treating snoring
• An average decrease of 60% of sleep disruptions and respiratory events during sleep
• Improving the quality of life and sleepiness
• Decrease of more than 25% of the Epworth sleepiness score (daytime sleepiness)

Very good acceptance

• 94% of patients still under treatment after 15 months on average
• 66% of patients wear the device all night 7 nights a week

(1) Navailles et col., Efficacy and Compliance of Innovative Mandibular Advancement Device, Rome,  Congrès Modial d´O.R.L. I.F.O.S. 2005

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.

FDA Approval:
Date of FDA Approval:
FDA Registration Number:

NORAD is an autotitratable, 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.

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 as a unit and not as separate functions.The Nose Breathe for Heavy Snorer is constructed of EVA (ethyl vinyl acetate) material, and is very comfortable. Upper and lower impressions are required and are custom-fitted. The bite is set in the normal occlusion. There is no pressure on the TMJ, and thereby, it will prevent permanent bite shift from occurring.The research study, “A New Tongue-Retaining Oral Appliance” by Rosalind Cartwright, et al. at Rush University Medical Center, Chicago was presented at the 18th Annual APSS Convention at Philadelphia in June 2004. The Abstract was published in the Journal of Sleep, Vol. 27, June 2004, 412. The result: nasal breathing can effectively control snoring and mild sleep apnea.The early control of snoring and mild sleep apnea is important because recent studies are showing that within six years heavy snoring could lead to high blood pressure, stroke, and OSA.FDA Approval: May 28, 2002
FDA Registration Number: K013687

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
• 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.

MAXIMAL INTRAORAL VOLUME

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.

SYNERGISTIC FUNCTION FOR MAXIMAL RESULTS 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 http://www.oasyssleep.com

FDA Approval:
Date of FDA Approval:
FDA Registration Number:K030440

Patients who are unable to be compliant with a nasal mask due to claustrophobia, head aches due to chinstraps or head gear and complaints of mask leaks leading to eye irritation, sinusitis may benefit by using oral mask ventilation with the OPA P. Oral positive air pressure delivered by a newly conceived proprietary dental appliance (OPA P) is a treatment alternative to nasally applied positive air pressure (CPAP or BiPAP). Mandibular advancement and modification of the upper airway structures is thought to enlarge the airway or reduce its collapsibility.The OPAP® is an oral appliance which incorporates an airway and mandibular position in its design and function. Lt assures an airway to the retropharynx during sleep and allows delivery of positive air pressure (CPAP or BiPAP) through it if needed. The combination of mandibular positioning and the creation of an airway allows for an alternative mode of treatment for the collapsible airway found in O SA patients. This type of dental appliance may be
used for mild to severe cases of OSA.Evaluation of the patient for the suitability of an oral appliance from a medical and dental standpoint is first determined. A referral to a dental sleep specialist is then made. A complete dental exam including panorex, cephalometrics in addition to sonography of the TMJ joint was obtained prior to taking dental impressions may be considered. A bite registration is then obtained, allowing the OPAP® appliance to be custom made to the patients dental impressions. Once a comfortable fit is obtained the OPAP® was connected to CPAP or BiPAP by the standard tubing. A titration polysomnogram test is then recommended with the O PAP and positive air pressure.Primary complaints with the OPAP® included oral drying, excessive salivation, discomfort with exhaling against CPAP. Drying improves with the use of an inline humidifier. Excessive salivation improved with adaptation and continued use of the oral appliance. Discomfort with exhalation against orally delivered CPAP improved with the use of orally delivered BiPAP. The OPAP® has been designed for patients with and without teeth­Data presented to the FDA demonstrated the OPAP® appliance delivered oral air pressure capable of producing a reduction of the AHl in mild to severe cases of OSA to the same level of efficacy as nasal mask delivery. This type of dental appliance may serve to be a therapeutic alterative to nasal CPAP and in certain mild cases this oral appliance is by itself capable of treating mild OSA.FDA Approval:
Date of FDA Approval: Oct. 18,1999
Date of Canadian Approval: Feb. 25, 1999
FDA Registration Number: K991926
Canadian Approval Number: 18949

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.FDA Approval: Approved for both Snoring and OSA
Date of FDA Approval: May, 1996
FDA Registration Number: K960673

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 temperomandibular 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 temperomandibular joint.

FDA Approval: Approved for both snoring and OSA
Date of FDA Approval: Nov 29, 1995
FDA Registration Number: K954530

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.FDA Approval: Approved for Snoring and OSA

Date of FDA Approval: September 18, 1997

FDA Registration Number: K972424

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
FDA Approval:
Date of FDA Approval:
FDA Registration Number:

 

The SnoreSilencer(tm) Pro is an easy-to-use and comfortable heat-and-fit mandibular advancement device, for the reduction or elimination of snoring and/or to treat OSA. Patients can take it home the same day it is fit. For patients considering a mandibular advancement device, the SnoreSilencer Pro is a quick and cost-effective introduction to the technology. The device is also an alternative for noncompliant CPAP users or those who want a more accessible treatment alternative when traveling.

With its patented hinge technology and soft pliable material, the device is close to custom in comfort and ability to adjust jaw advancement, without the long waiting period for lab fabrication. The unique Precision 3 Advancement System uses three separate lower trays, each with a fixed pin setting. This facilitates three different advancement levels to help patients can reach a most satisfactory level of treatment.

FDA 510K: K033822
February 6, 2004

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 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. 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.FDA Approval: Approved for both Snoring and OSA
Date of FDA Approval: July 22,1999
FDA Registration Number: K991449

The SnoreFree 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.

FDA Approval: Unclassified
Date of FDA Approval: Jan. 4, 1996
FDA Registration Number: K955336

The SomnoDent 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. If required, a part can be added to make the device adjustable. This 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 Custom-fitted Additionally, the SomnoDent 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.

FDA Approval received July 2005

The SomnoDent 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. If required, a part can be added to make the device adjustable. This 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 Custom-fitted Additionally, the SomnoDent 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.

FDA Approval received July 2005

One-part thermoplastic mandibular advancement device to treat snoring and mild to moderate obstructive sleep apnoea. 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. The monobloc appliance exhibits the following features and advantages:

• Easy fitting within minutes, preferably by physicians or their trained staff
• Clinical efficacy well proven by several clinical trials performed with the SomnoGuard® with success rates between 50 to 80% in reducing snoring and RDI (i.e. Respiratory Disturbance Index). Literature references and detailed actual clinical trial outcome data is published on www.tomedcare.com
• Normally very well tolerated. Minor and temporary side effects refer mainly to hypersalivation and morning discomfort
• Average life of about one year, and thus considered for short to medium term use
• The most cost-effective option to treat snoring and sleep apnea

Dental lab made two-part mandibular adjustable positioner to treat snoring and mild to moderate sleep apnoea. The SomnoGuard AP Pro can easily be constructed from common acrylic/elastomeric thermoform dental materials in any detal 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 inndestructable, inexpensive and can most often be reused when the oral appliance has to re-made for some reason. As well as the advantages of the SomnoGuard AP, the dental device SomnoGuard AP Pro provides the additional benefit that even patients with missing teeth or dentures can wear it. SomnoGuard AP Pro is considered for long term use between about three to five years or longer.

FDA Approval received for the complete line of SomnoGuard oral appliances (the 1-part boil & bite devices SomnoGuard and SomnoGuard 2.0, the 2-part adjustable boil & bite SomnoGuard AP and the two part custom made SomnoGuard AP Pro for fabrication by dental labs) the FDA 510(k) approval under the clearance number K061688 on September 8, 2006

The SUAD is also a custom-made appliance that is made of a heat-sensitive acrylic and is reinforced by a metal framework. The SUAD adjustment mechanism (Herbst) is positioned on the sides of the device and consists of a piston that slides within a tube. The appliance is comfortable on the teeth and the mechanism allows good freedom of movement of the jaw. Therefore it is used frequently in patients who tend to grind their teeth heavily. The position of the jaw can be adjusted by using small rings that slide over the piston and when the tube is positioned over the piston it will advance the jaw the width of the ring. Small elastics (rubber bands) are used to keep the jaw from falling open during the night although the patient is able to partially open the mouth, which can improve comfort when using the appliance.

The Thornton Adjustable Positioner (TAP) is a custom-made two piece adjustable appliance that is worn while sleeping. The trays of the appliance snap over the upper and lower teeth and hook together. The design is based on the same principle as cardiopulmonary resuscitation, CPR. The airway must be opened to allow air to pass through the throat. The TAP holds the lower jaw in a forward position so that it does not shift nor fall open during the night. This prevents the airway from collapsing. The more you pull your jaw forward, the more your airway will open.

The TAP is the only mandibular advancement device that can be adjusted easily by the patient or practitioner while in the mouth. This feature allows the patient to always be in control of their treatment. The unique design also allows the patient to fine-tune their treatment position at home to achieve maximum results.

Most patients experience relief the very first night they wear their TAP. Although it may take up to a week to get used to wearing a TAP appliance, this is a small hurdle for patients. Nine in ten patients wear the device all night, every night  making the TAP a highly effective solution for both snoring and sleep apnea.

Features

• Patient-friendly
• Superior results
• Easy to fit
• Infinitely adjustable
• Precise control of advancement
• Interchangeable hooks
• Freedom for lateral movement
• More room for tongue
• Allows lips to close

The TAP® can help prevent conditions linked to sleep apnea:

• Chronic daytime sleepiness
• High blood pressure
• Heart attack
• Stroke
• Heartburn, reflux
• Morning headaches
• Depression

FDA Approval: Approved for both snoring and OSA
Date of FDA Approval: August 21, 1997
FDA Registration Number: K972061

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: Approved for treatment of snoring
Date of FDA Approval: August 13, 1997
December 2014 the FDA has cleared/approved the Adjustable TheraSnore for the treatment of Obstructive Sleep Apnea.The FDA 510(k) approval is K140663.