Atlas FDA

LRK

214 FDA 510(k) clearances · Product code

142 daysmedian time to decision
327 days90th percentile
214clearances measured

FDA profile

Official device name
Device, Anti-Snoring
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 49 · 2022: 40 · 2023: 50 · 2024: 185 · 2025: 660 · 2026: 761
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SnØreNegatØr (K261912)DnB Innovations, LLC2026-07-31
Virtus (K261366)Somnomed, Inc.2026-06-12
Snorbliss® Anti-Snoring Device (K261251)Endeavor Commerce, LLC2026-06-11
Dormiva Anti-Snoring Mouth Guard (K261134)Koncept Innovators, Inc.2026-05-14
ShaeferH (K252942)Shaeferh, LLC2026-04-10
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (K253845)Ram.Shaw Pte. , Ltd.2026-03-03
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (K252531)Myofunctional Research Co.2026-03-02
Park Dental Nylon MAD (K252976)Park Dental Research Corp.2025-12-18
QuietLab Pro (K253868)QuietLab, LLC2025-12-05
Hushd Avera (K252161)Good Sleep CO Pte , Ltd.2025-11-25
AIO Breathe (K252525)Aiomega, LLC2025-11-06
NightGuard Aire Max (K252698)Nightguard Express, LLC2025-11-03
Difiney Advanced Anti Snoring Device 4.0 (K253355)Fissiontech, LLC2025-10-29
Hushd Pro Z-Link (K251784)Good Sleep CO Pte , Ltd.2025-10-24
Mandibular Advancement Device L07 (K251628)Dcstar, Inc.2025-10-22
Anti Snore Mouthpiece (K250028)Dongguan Yiyao Science & Technology Development Co., Ltd.2025-10-03
Double Tube Herbst Appliance (K243752)The Tmj Clinic PC2025-09-17
Nylon flexTAP(R) (K252374)Airway Technologies D/B/A Airway Management2025-09-11
Oniris; Oniris Plus (K250353)Oniris2025-09-04
SleepRight Snore Aid (K250122)Splintek, Inc.2025-05-19
Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue (K250482)Fissiontech, LLC2025-05-08
DNA Appliance (K234089)Vivos Therapeutics2024-09-16
Hushd Pro Avera (K232025)Good Sleep CO Pte , Ltd.2024-05-09
EMA 3D (K232735)Ema Sleep Incorporated2024-05-03
Difiney Anti Snoring Device (K233850)Fissiontech, LLC2024-04-18
airVata™ (K240427)Gelb Practice Solutions, Inc.2024-02-14
Aniti-Snore Mouthguard+ (K231138)Oscimed SA2024-01-16
C.A.R.E. Appliance (DNA, mRNA, mmRNA) (K230947)Vivos Therapeutics, Inc.2023-11-28
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) (K233434)Prismatik Dentalcraft, Inc.2023-11-14
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece (K231663)Innovative Health Technologies (Nz), Ltd.2023-09-18
ApneaRX Pro (K223901)Apnea Sciences Coporation2023-09-01
Emerald Herbst (K223624)Island Dental Lab, Inc Dba Emerald Dental2023-05-10
DNA Appliance (K222872)Vivos Therapeutics, Inc.2022-12-30
SilentZPro 2.0 (K220688)Shinrin-Yoku Traders, LLC2022-12-02
SNOR LOCK (K222475)Solbaro Co., Ltd.2022-11-10
CUSTMBITE Snoring System (K221322)Dental Choice Holdings, LLC2022-10-27
Soft Palate Elevator (K222127)The Tmj Clinic PC2022-10-24
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring (K221889)Prosomnus Sleep Technologies2022-10-06
Soundly Anti Snoring Device (K220330)Greystone Ip, Ltd.2022-09-08
ZQuiet Advance (K213088)Sleeping Well, LLC2022-06-15
Respire Clear (K214096)Respire Medical, LLC2022-05-31
Morpheus (K210636)S4S UK , Ltd.2022-02-15
Elevo Snoring Intervention Set (K213475)Zelegent, Inc.2022-01-27
EndSnorZ Sleep Appliance (K211069)Prismatik Dentalcraft, Inc.2021-10-26
SmartGuard Anti-Snoring Device (K200657)Smartguard Rx, Inc.2021-08-23
mmRNA appliance (K210203)Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)2021-08-19
Snore Bandit (K210910)Snorebandit, LLC2021-07-01
Silent Nite Sleep Appliance with the Glidewell Hinge (K210694)Prismatik Dentalcraft, Inc.2021-06-16
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) (K203606)Meris Investment Group2021-03-10
Classic (K203477)Orthoapnea S.L.2021-02-25
Advanced Dental Appliance (K203462)Dasoft Partners2021-02-19
NOA Sleep Apnea and Snoring Device (K202651)Orthoapnea S.L.2021-02-12
Vital Sleep (K201719)The Snore Reliever Company, LLC2021-01-14
Somnos Anti-Snoring Mouth Guard (K201484)Koncept Innovators, LLC2020-11-23
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring (K202529)Prosomnus Sleep Technologies, Inc.2020-11-20
Diamond Digital Sleep Orthotic (DDSO) (K202499)Diamond Orthotic Laboratory2020-09-03
Respire Pink AT (Hard, Hard/Soft, EF) (K192127)Respire Medical Holdings2020-02-05
MPowRx Snoring Solution (also known as Good Morning Snore Solution) (K193239)Mpowrx Health and Wellness Products 2012, Inc.2020-01-03
SleepTight Mouthpiece STZ (K191618)Michael D Williams Dds PA2019-12-11
Sapphire Dorsal Comfort Fit (K181416)Crane Dental Laboratory, Inc.2019-09-17
O2Vent Optima (K190236)Oventus Manufacturing Pty, Ltd.2019-08-29
Silent Nite sl (K183270)Prismatik Dentalcraft, Inc.2019-07-17
Twilite Appliance (K190687)Stephen J Harkins, Dds, PC2019-07-02
TD Clip (K190051)Zephyr Sleep Technologies, Inc.2019-06-07
SomnoDent Avant (K183443)Somnomed, Inc.2019-05-08
PureSleep (OTC use) (K190058)Sleep Science Partners, Inc.2019-04-11
ZAPnea Oral Appliance (K173064)B. Fareid, Dds, PC2019-03-08
Kava and Kava with Herbst (K182661)Sketchpad Innovations, LLC2019-02-13
TrueDorsal Devices (K180691)True Function Laboratory, Inc.2019-02-11
Zyppah Anti-Snoring Device (K182312)Always More Marketing2019-01-24
SLEEPAPP (K182202)Comfort Acrylics, Inc.2019-01-11
Elevo® Kit Snoring Intervention Device (K181107)Zelegent, Inc.2018-12-06
ApnoDent Appliance (K181123)Apnomed, Inc.2018-11-21
Oral Device OA, Oral Device S (K181396)Passion For Life Healthcare (Uk) Limited2018-11-16
myTAP2 (K181482)Airway Management, Inc.2018-08-31
Advanced Dental Applicance (K172991)Dasoft Partners2018-07-10
Express 4 Sleep appliance/CPAP Sidekick appliance (K173856)Moses Appliances, LLC2018-06-26
ZQuiet (K180124)Sleeping Well, LLC2018-06-12
REST EAZY Appliance (K172760)Insert Molding Solutions, Inc.2018-03-26
The Panthera Anti-Snoring X3 Device (K171576)Panthera Dental, Inc.2018-02-22
Snorer's Friend (K171529)Scope Healthcare Technologies Pty, Ltd.2018-01-02
Meridian PM (K170053)The Center For Craniofacial & Dental Sleep Medicine2017-11-28
True Function Adjustable Herbst Appliances (K170578)True Function Laboratory, Inc.2017-11-24
SnoreRx (K170825)Apnea Sciences Corporation2017-08-18
O2Vent W (K171316)Oventus Manufacturing Pty, Ltd.2017-07-11
ASD Oral Appliances (K163580)American Sleep Dentistry2017-06-08
Respire Pink Series with DentiTrac (K170692)Respire Medical Holding2017-05-26
Fuselier Intraoral Nighttime Device (FIND) (K161980)Fuselier Enterprises, LLC2017-02-07
BluePro (K162192)Bluesom2016-12-15
HYPNOSPAD (K152660)Somnics, Inc.2016-11-09
O2VENT T (K161832)Oventus Manufacturing Pty, Ltd.2016-09-23
SomnoDent ALPHA (K162306)Somnomed, Inc.2016-09-20
Noiselezz (K160531)Firma Ingemarsson2016-09-01
SnoreRx (K153200)Apnea Sciences Corporation2016-08-09
Apinator (K160123)Allen J. Moses, Dds, Ltd.2016-07-12
SICAT OPTISLEEP (K153291)Sicat GmbH & Co. KG2016-03-31
Oniris (K150566)Sas Oniris2016-03-21
OVENT (K160234)Oventus Manufacturing Pty, Ltd.2016-03-17
Respire Blue Series-EF (K152292)Respire Medical Holding2015-12-07
Oravan Herbst (K152159)Oravanosa, LLC2015-10-29
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