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Somnos Anti-Snoring Mouth Guard

by Koncept Innovators, LLC 510(k)

Active United States

510(k) K201484

Overview

The Somnos Anti-Snoring Mouth Guard is a self-fitting, adjustable mandibular advancement device (MAD) for home use by adults to reduce snoring. It consists of two prefabricated, single-piece trays made of thermoplastic resin (ethylene-vinyl-acetate and polycarbonate) that are customized via a 'boil and bite' method.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code LRK. It is classified as a Class II device for anti-snoring purposes under the dental specialty category and is regulated under number 872.5570.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201484 Date23 Nov 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Somnos Anti-Snoring Mouth Guard used for?

    The Somnos Anti-Snoring Mouth Guard is a self-fitting, adjustable mandibular advancement device (MAD) designed for home use by adults to reduce snoring. It works by positioning the lower jaw slightly forward to help keep the airway open during sleep.

  • How is the Somnos Anti-Snoring Mouth Guard customized and used?

    The device consists of two prefabricated, single-piece trays made of thermoplastic resin that are customized using a 'boil and bite' method. The trays are softened in hot water, then molded to the user's teeth and gums for a personalized fit.

  • Is the Somnos Anti-Snoring Mouth Guard reusable or single-use?

    The Somnos Anti-Snoring Mouth Guard is supplied as a single-use product. It is designed to be used once and then replaced, as the thermoplastic material may lose its effectiveness and proper fit after extended use.

  • What is the regulatory classification of the Somnos Anti-Snoring Mouth Guard?

    The device is regulated under FDA 510(k) clearance with product code LRK. It is classified as a Class II device for anti-snoring purposes under the dental specialty category and is regulated under number 872.5570.