Atlas FDA

OBR

46 FDA 510(k) clearances · Product code

116 daysmedian time to decision
264 days90th percentile
46clearances measured

FDA profile

Official device name
Mouthguard, Over-The-Counter
Device class
Unclassified
Medical specialty
Unknown
FDA definition
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Adverse events (MAUDE)
2017: 24 · 2018: 23 · 2019: 29 · 2020: 15 · 2024: 18 · 2026: 17
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
G-Series Grind Guard (K260790)ASESSO HEALTH, Inc.2026-06-25
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (K252485)1987 Media Limited2026-04-10
Owl Night Guard (K253641)Owl Dental Lab, Inc.2026-02-26
enCore Night Guard (K252004)Encore Guards2025-11-25
Remi Custom Night Guard (K251778)Remi2025-10-17
Dentemp Pro-Comfort Dental Guard (K250456)Doc Brands, Inc.2025-05-19
Anti Grinding Guard (K240810)Xiamen Yizhou Imp. & Exp. Co., Ltd.2024-05-24
Goyo Mouthpiece S (K232238)Dimedikorea2024-04-17
Mouth Guard (ATG0603R) (K231865)Reazeal Corp2023-11-06
FBCC Night Guard (K221369)Fbcc, Inc.2022-11-18
Protect-It Custom Fit Dental Guard (K222424)Doc Brands, Inc.2022-10-07
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706)Splintek, Inc.2021-12-13
NTI ClenchGuard (K211158)Boyd Research, Inc.2021-09-17
DenTek Fresh Protect Dental Guard (K202974)Medtech Products, Inc.2020-12-22
SleepRight ProRx Custom Dental Guard (K193577)Splintek, Inc.2020-06-01
ClenchGuard (K181005)Boyd Research, Inc.2020-01-15
CustMBite Dental Guard (K183315)Dental Choice Holdings, LLC2019-08-23
LunaGuard Nighttime Dental Protector (K191033)Mckeon Products2019-08-05
Bright Guard (K181099)Koncept Innovators, LLC2019-01-18
DenTek Ultimate Dental Guard (K180933)Medtech Products, Inc.2018-09-17
Bruxor (K172452)Sleep Specialties, LLC2018-01-11
SleepRight ProRx Custom Dental Guard (K172223)Splintek, Inc.2017-11-17
Ora-GUARD Dental Grind Guard (K150492)Bite Tech, Inc.2016-02-19
Ready-Fit (K151149)Den Tek Oral Care, Inc.2015-09-30
THE BITE GUARD (K132469)International Profit Builders, Inc.2014-02-28
GRINDGUARD (K133037)Grind Guard Technologies, LLC2014-01-23
REST ASSURED EXTRA COMFORT NITE PROTECTOR (K133423)Ranir, LLC2013-12-20
NEW COMFORT-FIT DENTAL GUARD (K123849)Den Tek Oral Care, Inc.2013-01-10
PROTECH DENT (K121272)Akervall Technologies, Inc.2012-10-15
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD (K113326)Oralabs, Inc.2012-06-27
REST ASSURED GENERATION III DENTAL PROTECTOR (K120103)Ranir, LLC2012-02-03
REST ASSURED READY TO WEAR NITE PROTECTOR (K112879)Ranir, LLC2012-01-27
BRUX MOUTHGUARDS (K111310)Dental Arte, Inc.2011-12-08
SLEEPRIGHT (K100545)Power Products, Inc.-Splintek2010-06-04
GRIND NO MORE GENERATION II (K094020)Ranir, LLC2010-01-25
REST ASSURED GENERATION II DENTAL PROTECTOR (K091792)Ranir Corporation2009-07-08
CUSTOM COMFORT NIGHTGUARD VERSION 2 (K091660)Den Tek Oral Care, Inc.2009-06-12
GRIND NO MORE VERSION 2 AND 3 (K091175)Ranir, LLC2009-05-08
CUSTOM COMFORT NIGHTGUARD (K083400)Den Tek Oral Care, Inc.2008-12-11
GRIND NO MORE (K082301)Placontrol, Inc.2008-10-06
IMPROVED COMFORT-FIT NIGHTGUARD (K081669)Den Tek Oral Care, Inc.2008-07-10
STRESSGARD NIGHTGUARD (K072968)Totalgard Corporation2008-07-01
GRIND GUARD (K073446)Archtek, Inc.2008-02-08
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT (K073220)Prestige Brands, Inc.2007-12-19
DEN TEK COMFORT FIT NIGHTGUARD (K072147)Den Tek Oral Care, Inc.2007-08-30
REST ASSURED NITE PROTECTOR (K063229)Ranir, LLC2006-12-19

Track OBR automatically

Every clearance here is in the API, with alerts when new ones post.