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Anti-Snoring / Sleep Apnea Device

by Tomed Dr. Toussaint GmbH

510(k) K061688

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 NumberK061688 Date8 Sep 2006ClearedStatusActive

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  • Withdrawn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)

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

Overview

AI-generated summary, 1 Oct 2026

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

This device is an anti-snoring and sleep apnea device, classified as a mandibular advancement device intended for the treatment of snoring and obstructive sleep apnea syndrome. It is a dental device designed to advance the mandible to maintain airway patency during sleep.

It is supplied as a reusable device, manufactured by Tomed Dr. Toussaint GmbH, and has received FDA 510(k) clearance under K061688 with product code LRK and regulation number 872.5570. The device is indicated for use in dental applications and is intended for the treatment of snoring and obstructive sleep apnea syndrome.

Other devices from Tomed Dr. Toussaint GmbH

Questions

AI-generated answers, 1 Oct 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 ANTI-SNORING / SLEEP APNEA DEVICE used for?

    This device is a mandibular advancement device intended for the treatment of snoring and obstructive sleep apnea syndrome. It works by advancing the mandible to maintain airway patency during sleep, which helps reduce airway collapse and improve breathing. It is specifically designed for dental applications in managing these conditions.

  • Is the ANTI-SNORING / SLEEP APNEA DEVICE reusable or single-use?

    The device is supplied as a reusable device, meaning it is designed for multiple uses over time with proper cleaning and maintenance. It is not intended for single-use disposal. Reusability is supported by its construction and intended use in dental applications where durability and hygiene are managed through clinical protocols.

  • What regulatory clearance does the ANTI-SNORING / SLEEP APNEA DEVICE have?

    The device has received FDA 510(k) clearance under submission number K061688. It was determined to be substantially equivalent to a predicate device and is classified under product code LRK and regulation number 872.5570. This clearance permits its marketing for the treatment of snoring and obstructive sleep apnea syndrome in the United States.