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Dormiva Anti-Snoring Mouth Guard

by Koncept Innovators, LLC 510(k)

Active United States

510(k) K261134

Overview

The Dormiva Anti-Snoring Mouth Guard is a Mandibular Advancement Device (MAD), classified as a removable intraoral anti-snoring device. It is designed to reduce snoring by repositioning the lower jaw (mandible) forward, creating an open airway during sleep. This device is intended for use in adult patients aged 18 years or older as a non-invasive aid for snoring management.

This device is supplied as a self-fitting, adjustable intraoral appliance and is intended for single-use per patient. It is classified under FDA regulation 872.5570 and received FDA 510(k) clearance (K261134) as substantially equivalent to a predicate device. The product code LRK identifies it within the dental device category, and it is manufactured by Koncept Innovators, LLC. No specific sterility or MRI safety information is provided in the regulatory data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK261134 Date14 May 2026ClearedStatusActive

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
FDA applicant
Koncept Innovators, Inc.
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Koncept Innovators, LLC

Questions

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

    The Dormiva Anti-Snoring Mouth Guard is a Mandibular Advancement Device (MAD) intended for adult patients aged 18 and older. It works by repositioning the lower jaw forward to create an open airway during sleep, helping to reduce snoring as a non-invasive aid.

  • How is the Dormiva Anti-Snoring Mouth Guard supplied?

    This device is supplied as a self-fitting, adjustable intraoral appliance. It is designed for single-use per patient, meaning each unit is intended for one individual’s use only.

  • Is the Dormiva Anti-Snoring Mouth Guard sterile?

    The regulatory data does not specify any sterility requirements or claims for the Dormiva Anti-Snoring Mouth Guard. Users should follow manufacturer guidelines for handling and use.

  • Can the Dormiva Anti-Snoring Mouth Guard be reused?

    No, the Dormiva Anti-Snoring Mouth Guard is intended for single-use per patient. Reuse is not recommended as it may compromise hygiene and effectiveness.

  • What regulatory approval does the Dormiva Anti-Snoring Mouth Guard have?

    The Dormiva Anti-Snoring Mouth Guard received FDA 510(k) clearance (K261134) and is classified under FDA regulation 872.5570 as substantially equivalent to a predicate device. It is categorized under the dental device product code LRK.