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Somnowell Mandibular Advancement Appliance

by Somnowell, Ltd.

510(k) K150941

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150941 Date22 May 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Somnowell Mandibular Advancement Appliance (MAA)
510(k) Number
FDA Product Code
LRK
FDA applicant
Somnowell , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Somnowell Mandibular Advancement Appliance is a custom-fabricated, removable intraoral device designed to treat snoring and mild-to-moderate obstructive sleep apnea. It functions by maintaining an open airway throughout sleep through the use of two customized chrome cobalt frameworks that conform to the patient's upper and lower dentition.

These frameworks are connected bilaterally via a stainless steel telescoping Herbst mechanism. This device is regulated as a Class 2 dental device and has received FDA 510(k) clearance.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Somnowell Mandibular Advancement Appliance used for?

    This device is indicated for the treatment of snoring and mild-to-moderate obstructive sleep apnea. It functions by maintaining an open airway during sleep.

  • How does the device function?

    The appliance uses two customized chrome cobalt frameworks that conform to the patient's upper and lower dentition. These frameworks are connected bilaterally by a stainless steel telescoping Herbst mechanism to maintain an open airway.

  • Is this a custom-made device?

    Yes, the Somnowell Mandibular Advancement Appliance is a custom-fabricated, removable intraoral device designed to fit the specific dentition of the patient.

  • What is the regulatory status of this device?

    The Somnowell Mandibular Advancement Appliance is regulated as a Class 2 dental device and has received FDA 510(k) clearance.