Skip to content

IST Snoring Appliance

by Dental Crafters 510(k)

Active United States

510(k) K090911

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090911 Date11 Sep 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
LQZ
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 IST Snoring Appliance is a jaw repositioning device designed to address snoring issues. It functions by repositioning the jaw to help maintain an open airway during sleep, which can reduce or eliminate snoring.

This device is supplied as a non-sterile, reusable appliance and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code LQZ and is manufactured by Dental Crafters in Marshfeld, WI.

Questions

AI-generated answers, 23 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 IST Snoring Appliance used for?

    The IST Snoring Appliance is a jaw repositioning device designed to address snoring issues by repositioning the jaw to help maintain an open airway during sleep, which can reduce or eliminate snoring.

  • Is the IST Snoring Appliance sterile and single-use?

    The IST Snoring Appliance is supplied as a non-sterile, reusable appliance. It is not intended for single-use and should be properly cleaned and maintained between uses according to the manufacturer's instructions.

  • What are the regulatory specifications for the IST Snoring Appliance?

    The IST Snoring Appliance is authorized under FDA 510K clearance with product code LQZ. It is classified as a Class II device and was manufactured by Dental Crafters in Marshfeld, WI. It is not intended for MRI environments.

  • How should the IST Snoring Appliance be stored?

    The IST Snoring Appliance should be stored in a clean, dry place when not in use. Proper storage helps maintain the device's condition and functionality over its lifespan as a reusable appliance.