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To reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

Like these predicate devices, Somnofit is intended as an aid in the alleviation of snoring by positioning the lower jaw slightly forward thereby freeing the air intake and releasing back the tongue thereby decreasing air obstruction and turbulence. The device is normally placed in users' mouth each evening prior to sleeping and removed from the mouth the following morning. The device fits one user, is multi-use and cleaned daily.

The Somnofit anti-snoring device consists of:

• Lower plate fitted over lower teeth
• Upper plate fitted over upper teeth
• Hook mechanism, two located on right and left side of upper plate, four hooks on lower plate, two on left side and two on right side used to connect two bands one on the right upper and right lower plates, the other on the left upper and left lower plates.
• A floating thermometer
• A ventilated storage box
• A packet of 100 orthodontic rubber bands
• Instructions

The two buccal mouldings (upper and lower) are designed for universal application in adults with the use of one-size-fits all. The dentist or physician takes a dental impression, by immersing each moulding in hot water, as indicated with the included thermometer in order to soften the impressible plastic material then pressing the plates against the user's upper and lower jaws in order to form a fitting to the size dimensions of user's jaws and teeth. Once individually fit the first time, there is no need to reheat/remold the two plates. The upper and lower jaws fittings are linked by way of two orthodontic elastic bands connected by way of hooks located on the right and left front part of the plates. Two sets of hooks are present on both sides of the lower plate to allow the user to choose a looser or tighter tension of the bands. The upper single hook is located in front of the lower two sets of hooks. This way the bands thrust the lower jaw forward a few millimeters in front of the upper jaw. The elastic bands permit full lateral and vertical movement of device as well as some horizontal movement in user's mouth.

Encompassed inside the outer layer is a "skeleton" band, which is rigid in material but is made of a chain of rectangles with gaps in between. The gaps allow the whole band to optimally fit to the width of each tooth. This provides for a better fit over most of the user's teeth. With the molding pre-fitted to the user's dental morphology, the elastic traction is distributed over the 18- to 24- teeth.

This document refers to a 510(k) premarket notification for the Somnofit anti-snoring device. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, I cannot provide the requested information. The document primarily describes:

• Device Description and Intended Use: Somnofit is a Mandibular Advancement Device (MAD) intended to reduce snoring and mild to moderate obstructive sleep apnea by positioning the lower jaw forward.
• Substantial Equivalence: It claims equivalence to several predicate anti-snoring devices (Respironics Silencer, SUAD Device, SleepBite, TAP, NorAD) based on similar design and function.
• Risk Profile: A table outlines identified risks (intraoral soreness, oral breathing obstruction, tooth movement) and special controls to mitigate them.
• Regulatory Communication: Correspondence from the FDA affirming substantial equivalence and allowing the device to be marketed.

To answer your request, a different document containing a study report with acceptance criteria and performance data would be needed.

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