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The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Avant device is an intraoral device used for treating Snoring and Sleep Apnea. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Avant is a modification to the SomnoDent Flex (K073004). The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range from -1.0mm to +8.0mm.

The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.

The SomnoDent ALPHA is a device that functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device consists of two generic splints, which fit over the upper and lower teeth. The lower splint is held in a protrusive position by an advancement mechanism. The device advances the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnea symptoms.

The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be seep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment. This submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®

The SomnoDent Fusion is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Fusion is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Herbst is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent G2 device is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change (which to an addition of a differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.

The SomnoBrux Splints are intraoral devices used for treating bruxism. They consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.

The Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable components. The device functions as a mandibular repositioner, which acts to increase the patients Pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has adjustment mechanisms enabling the amount of mandibular advancement to be set by the dentist or physician at the time of the device fitting. The Pantino Pro Positioner is offered in two model designs. The Pantino Pro "A" has a single interlocking mechanism centrically located on the anterior occlusal surface of the upper and lower arches. This design offers lateral movement of the maxillary and mandible for those patients who require this freedom of motion. The Pantino Pro "B" has dual interlocking mechanisms located parallel to one another on the left and right occlusal surfaces positioned as posterior as possible to maintain maximum protrusion and a comfortable fit for the patient. This model offers vertical adjustment control for those patients who require this dimension of vertical stability.

The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.