Product Code: OBR FDA unclassified

Mouthguard, Over-The-Counter

Unknown

The Over-The-Counter Mouthguard (product code OBR) is a dental device intended to protect the teeth and reduce damage caused by bruxism or nighttime teeth grinding, as well as to prevent the noise associated with grinding. It is sold directly to consumers without a prescription for self-management of bruxing habits. This device is FDA Unclassified (class U), meaning it has not been formally placed into a device class and the unclassified reason code indicates it is pending classification; it has no regulation number and no assigned medical specialty. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OBR
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252485	ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))	Apr 10, 2026	Substantially Equivalent	1987 Media Limited
K253641	Owl Night Guard	Feb 26, 2026	Substantially Equivalent	Owl Dental Lab, Inc.
K252004	enCore Night Guard	Nov 25, 2025	Substantially Equivalent	Encore Guards
K251778	Remi Custom Night Guard	Oct 17, 2025	Substantially Equivalent	Remi
K250456	Dentemp Pro-Comfort Dental Guard	May 19, 2025	Substantially Equivalent	Doc Brands, Inc.
K240810	Anti Grinding Guard	May 24, 2024	Substantially Equivalent	Xiamen Yizhou Imp. & Exp. Co., Ltd.
K232238	Goyo Mouthpiece S	Apr 17, 2024	Substantially Equivalent	Dimedikorea
K231865	Mouth Guard (ATG0603R)	Nov 06, 2023	Substantially Equivalent	Reazeal Corp
K221369	FBCC Night Guard	Nov 18, 2022	Substantially Equivalent	Fbcc, Inc.
K222424	Protect-It Custom Fit Dental Guard	Oct 07, 2022	Substantially Equivalent	Doc Brands, Inc.
K212706	SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard	Dec 13, 2021	Substantially Equivalent	Splintek, Inc.
K211158	NTI ClenchGuard	Sep 17, 2021	Substantially Equivalent	Boyd Research, Inc.
K202974	DenTek Fresh Protect Dental Guard	Dec 22, 2020	Substantially Equivalent	Medtech Products, Inc.
K193577	SleepRight ProRx Custom Dental Guard	Jun 01, 2020	Substantially Equivalent	Splintek, Inc.
K181005	ClenchGuard	Jan 15, 2020	Substantially Equivalent	Boyd Research, Inc.
K183315	CustMBite Dental Guard	Aug 23, 2019	Substantially Equivalent	Dental Choice Holdings, LLC
K191033	LunaGuard Nighttime Dental Protector	Aug 05, 2019	Substantially Equivalent	Mckeon Products
K181099	Bright Guard	Jan 18, 2019	Substantially Equivalent	Koncept Innovators, LLC
K180933	DenTek Ultimate Dental Guard	Sep 17, 2018	Substantially Equivalent	Medtech Products, Inc.
K172452	Bruxor	Jan 11, 2018	Substantially Equivalent	Sleep Specialties, LLC
K172223	SleepRight ProRx Custom Dental Guard	Nov 17, 2017	Substantially Equivalent	Splintek, Inc.
K150492	Ora-GUARD Dental Grind Guard	Feb 19, 2016	Substantially Equivalent	Bite Tech, Inc.
K151149	Ready-Fit	Sep 30, 2015	Substantially Equivalent	Den Tek Oral Care, Inc.
K132469	THE BITE GUARD	Feb 28, 2014	Substantially Equivalent	International Profit Builders, Inc.
K133037	GRINDGUARD	Jan 23, 2014	Substantially Equivalent	Grind Guard Technologies, LLC
K133423	REST ASSURED EXTRA COMFORT NITE PROTECTOR	Dec 20, 2013	Substantially Equivalent	Ranir, LLC
K123849	NEW COMFORT-FIT DENTAL GUARD	Jan 10, 2013	Substantially Equivalent	Den Tek Oral Care, Inc.
K121272	PROTECH DENT	Oct 15, 2012	Substantially Equivalent	Akervall Technologies, Inc.
K113326	ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD	Jun 27, 2012	Substantially Equivalent	Oralabs, Inc.
K120103	REST ASSURED GENERATION III DENTAL PROTECTOR	Feb 03, 2012	Substantially Equivalent	Ranir, LLC
K112879	REST ASSURED READY TO WEAR NITE PROTECTOR	Jan 27, 2012	Substantially Equivalent	Ranir, LLC
K111310	BRUX MOUTHGUARDS	Dec 08, 2011	Substantially Equivalent	Dental Arte, Inc.
K100545	SLEEPRIGHT	Jun 04, 2010	Substantially Equivalent	Power Products, Inc.-Splintek
K094020	GRIND NO MORE GENERATION II	Jan 25, 2010	Substantially Equivalent	Ranir, LLC
K091792	REST ASSURED GENERATION II DENTAL PROTECTOR	Jul 08, 2009	Substantially Equivalent	Ranir Corporation
K091660	CUSTOM COMFORT NIGHTGUARD VERSION 2	Jun 12, 2009	Substantially Equivalent	Den Tek Oral Care, Inc.
K091175	GRIND NO MORE VERSION 2 AND 3	May 08, 2009	Substantially Equivalent	Ranir, LLC
K083400	CUSTOM COMFORT NIGHTGUARD	Dec 11, 2008	Substantially Equivalent	Den Tek Oral Care, Inc.
K082301	GRIND NO MORE	Oct 06, 2008	Substantially Equivalent	Placontrol, Inc.
K081669	IMPROVED COMFORT-FIT NIGHTGUARD	Jul 10, 2008	Substantially Equivalent	Den Tek Oral Care, Inc.
K072968	STRESSGARD NIGHTGUARD	Jul 01, 2008	Substantially Equivalent	Totalgard Corporation
K073446	GRIND GUARD	Feb 08, 2008	Substantially Equivalent	Archtek, Inc.
K073220	THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT	Dec 19, 2007	Substantially Equivalent	Prestige Brands, Inc.
K072147	DEN TEK COMFORT FIT NIGHTGUARD	Aug 30, 2007	Substantially Equivalent	Den Tek Oral Care, Inc.
K063229	REST ASSURED NITE PROTECTOR	Dec 19, 2006	Substantially Equivalent	Ranir, LLC