OBR · Mouthguard, Over-The-Counter

· Class U

Overview

Product CodeOBR
Device NameMouthguard, Over-The-Counter
Device ClassClass U
Review Panel

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Recent Cleared Devices (20 of 45)

Showing 20 most recent of 45 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedApr 10, 2026SESE
K253641Owl Night GuardOwl Dental Lab, Inc.Feb 26, 2026SESE
K252004enCore Night GuardEncore GuardsNov 25, 2025SESE
K251778Remi Custom Night GuardRemiOct 17, 2025SESE
K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.May 19, 2025SESE
K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.May 24, 2024SESE
K232238Goyo Mouthpiece SDimedikoreaApr 17, 2024SESE
K231865Mouth Guard (ATG0603R)Reazeal CorpNov 6, 2023SESE
K221369FBCC Night GuardFbcc, Inc.Nov 18, 2022SESE
K222424Protect-It Custom Fit Dental GuardDoc Brands, Inc.Oct 7, 2022SESE
K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.Dec 13, 2021SESE
K211158NTI ClenchGuardBoyd Research, Inc.Sep 17, 2021SESE
K202974DenTek Fresh Protect Dental GuardMedtech Products, Inc.Dec 22, 2020SESE
K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.Jun 1, 2020SESE
K181005ClenchGuardBoyd Research, Inc.Jan 15, 2020SESE
K183315CustMBite Dental GuardDental Choice Holdings, LLCAug 23, 2019SESE
K191033LunaGuard Nighttime Dental ProtectorMckeon ProductsAug 5, 2019SESE
K181099Bright GuardKoncept Innovators, LLCJan 18, 2019SESE
K180933DenTek Ultimate Dental GuardMedtech Products, Inc.Sep 17, 2018SESE
K172452BruxorSleep Specialties, LLCJan 11, 2018SESE

Top Applicants

Innolitics

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