Skip to content

SnoreMaster Snore Remedy

by The Snoremaster Co.

510(k) K932932

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 NumberK932932 Date10 Feb 1995ClearedStatusActive

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  • Withdrawn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
LQZ
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 SnoreMaster Snore Remedy is a Jaw Repositioning Device, classified under FDA regulation 872.5570. This oral appliance is designed to reposition the lower jaw to reduce snoring by altering airway anatomy during sleep, addressing obstructive sleep-related breathing disorders.

Supplied as a single-use or reusable oral appliance, the SnoreMaster Snore Remedy is intended for use in dental settings. It is regulated under FDA 510(k) clearance (K932932) as a Class II device, with no explicit MRI safety or sterility requirements stated in the data. Sizes and adjustments are tailored to individual patient anatomy, and compliance with FDA’s dental advisory committee (DE) guidelines governs its distribution.

Questions

AI-generated answers, 20 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 SnoreMaster Snore Remedy primarily used for in clinical settings?

    The SnoreMaster Snore Remedy is designed as a jaw repositioning device to reduce snoring by altering airway anatomy during sleep. It targets obstructive sleep-related breathing disorders, helping patients who experience snoring due to airway obstruction. The device is tailored to individual patient anatomy and is intended for use in dental settings.

  • Is the SnoreMaster Snore Remedy available in single-use or reusable versions, and how is it adjusted?

    The SnoreMaster Snore Remedy is supplied as either a single-use or reusable oral appliance, depending on the clinical preference or patient needs. Adjustments are made to fit individual patient anatomy, ensuring proper positioning of the lower jaw to improve airflow and reduce snoring.

  • What regulatory pathway does the SnoreMaster Snore Remedy follow, and who oversees its distribution?

    The SnoreMaster Snore Remedy follows the FDA’s 510(k) clearance pathway, classified as a Class II device under regulation 872.5570. Its distribution is governed by compliance with the FDA’s Dental (DE) advisory committee guidelines, ensuring it meets dental-specific standards for jaw repositioning devices.

  • Are there any specific storage requirements mentioned for the SnoreMaster Snore Remedy?

    The provided data does not explicitly detail storage requirements for the SnoreMaster Snore Remedy. However, since it is intended for dental use and may be reusable or single-use, standard dental device storage practices—such as cleanliness, protection from contamination, and proper handling—should be followed to maintain its integrity and functionality.