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SnoreFree

by Scott Feldman Dds & Norman Shapiro Dds

510(k) K955336

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 NumberK955336 Date4 Jan 1996ClearedStatusActive

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  • Withdrawn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.

The SnoreFree is a dental device classified as an Anti-Snoring Device (Product Code: LRK), designed to address obstructive sleep apnea by repositioning the jaw to maintain an open airway during sleep. It functions as a mandibular advancement device, mechanically stabilizing the lower jaw in a forward position to reduce snoring and improve breathing patterns. This non-invasive approach targets the primary cause of snoring by preventing airway collapse during respiration.

SnoreFree is supplied as a reusable dental appliance, intended for use in a clinical or home setting under professional supervision. The device is not sterile upon packaging and requires cleaning and maintenance by the user. It is classified as a Class II medical device under FDA regulation 872.5570, with clearance through a Traditional 510(k) pathway. Available in adjustable sizes to accommodate different patient anatomies, it is regulated for dental use and requires proper fitting by a licensed practitioner to ensure efficacy and comfort.

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 SnoreFree device used for?

    The SnoreFree is designed as an anti-snoring device to address obstructive sleep apnea by mechanically advancing the lower jaw forward. This repositioning helps maintain an open airway during sleep, reducing snoring and improving breathing patterns. It targets the primary cause of snoring by preventing airway collapse.

  • Is the SnoreFree device reusable or single-use?

    The SnoreFree is a reusable dental appliance. It is intended for long-term use under professional supervision, with the user responsible for cleaning and maintenance between sessions. This design ensures cost-effectiveness and sustainability for patients.

  • How is the SnoreFree device supplied and does it require sterilization?

    The SnoreFree device is supplied non-sterile and is not intended for sterile use. It is meant to be cleaned and maintained by the user in either a clinical or home setting. Sterilization is not required as it is designed for reusable application under proper hygiene protocols.

  • What sizes or models of the SnoreFree device are available?

    The SnoreFree device is available in adjustable sizes to accommodate different patient anatomies. Proper fitting by a licensed dental practitioner is essential to ensure comfort and efficacy, as the device must be tailored to the individual’s jaw structure.

  • How should the SnoreFree device be stored?

    The SnoreFree device should be stored in a clean, dry place when not in use. Users should follow manufacturer guidelines for cleaning and maintenance to preserve its functionality and hygiene. Avoid exposure to moisture or extreme temperatures, which could compromise the material integrity.