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Zyppah Anti-Snoring Device

by Always More Marketing

510(k) K182312

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 NumberK182312 Date24 Jan 2019ClearedStatusActive

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  • Withdrawn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, 25 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 Zyppah Anti-Snoring Device is a dental device designed to control and treat snoring and mild to moderate sleep apnea. It works by gently moving the jaw forward and stabilizing the tongue to open the airway and eliminate snoring. The device features a patented tongue strap that distinguishes it from other anti-snoring mouthpieces.

The Zyppah Anti-Snoring Device is supplied as a single-use or reusable device, though specific sterility and storage information are not provided in the data. It is FDA 510(k) cleared with product code LRK and is classified as a class II medical device. The device is available in various sizes, though specific size details are not included in the provided information.

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