LRK · Device, Anti-Snoring

Dental · 21 CFR 872.5570 · Class 2

Overview

Product CodeLRK
Device NameDevice, Anti-Snoring
Regulation21 CFR 872.5570
Device ClassClass 2
Review PanelDental
3rd-Party ReviewableYes

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Classification Rationale

Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Recent Cleared Devices (20 of 210)

Showing 20 most recent of 210 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252942ShaeferHShaeferh, LLCApr 10, 2026SESE
K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.Mar 3, 2026SESE
K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.Mar 2, 2026SESE
K252976Park Dental Nylon MADPark Dental Research Corp.Dec 18, 2025SESE
K253868QuietLab ProQuietLab, LLCDec 5, 2025SESE
K252161Hushd AveraGood Sleep CO Pte , Ltd.Nov 25, 2025SESE
K252525AIO BreatheAiomega, LLCNov 6, 2025SESE
K252698NightGuard Aire MaxNightguard Express, LLCNov 3, 2025SESE
K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLCOct 29, 2025SESE
K251784Hushd Pro Z-LinkGood Sleep CO Pte , Ltd.Oct 24, 2025SESE
K251628Mandibular Advancement Device L07Dcstar, Inc.Oct 22, 2025SESE
K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd.Oct 3, 2025SESE
K243752Double Tube Herbst ApplianceThe Tmj Clinic PCSep 17, 2025SESE
K252374Nylon flexTAP(R)Airway Technologies D/B/A Airway ManagementSep 11, 2025SESE
K250353Oniris; Oniris PlusOnirisSep 4, 2025SESE
K250122SleepRight Snore AidSplintek, Inc.May 19, 2025SESE
K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLCMay 8, 2025SESE
K234089DNA ApplianceVivos TherapeuticsSep 16, 2024SESE
K232025Hushd Pro AveraGood Sleep CO Pte , Ltd.May 9, 2024SESE
K232735EMA 3DEma Sleep IncorporatedMay 3, 2024SESE

Top Applicants

Innolitics

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