OBR

FDA Product Code OBR: Mouthguard, Over-the-counter

To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Leading manufacturers include Splintek, Inc., Doc Brands, Inc. and Medtech Products, Inc..

Total

Cleared

133d

Avg days

2006

Since

Stable submission activity - 6 submissions in the last 2 years

Consistent review times: 137d avg (recent)

FDA 510(k) Cleared Mouthguard, Over-the-counter Devices (Product Code OBR)

46 devices

1–24 of 46

Cleared Apr 10, 2026

ClenchNoMore (CNM-1 (Mixed sizing))

Remi Custom Night Guard

Dentemp Pro-Comfort Dental Guard

Xiamen Yizhou Imp. & Exp. Co., Ltd.

Mouth Guard (ATG0603R)

Protect-It Custom Fit Dental Guard

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

DenTek Fresh Protect Dental Guard

K202974

Medtech Products, Inc.

Dental · 83d

Cleared Jun 01, 2020

SleepRight ProRx Custom Dental Guard

CustMBite Dental Guard

K183315

Dental Choice Holdings, LLC

Dental · 266d

Cleared Aug 05, 2019

LunaGuard Nighttime Dental Protector

Koncept Innovators, LLC

Dental · 267d

Cleared Sep 17, 2018

DenTek Ultimate Dental Guard

K180933

Medtech Products, Inc.

Sleep Specialties, LLC

Dental · 150d

About Product Code OBR - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code OBR since 2006, with 46 receiving FDA clearance (average review time: 133 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - OBR Product Code

FDA review times for OBR submissions have been consistent, averaging 137 days recently vs 132 days historically.

OBR devices are reviewed by the Dental panel. Browse all Dental devices →

FDA Product Code OBR: Mouthguard, Over-the-counter

FDA 510(k) Cleared Mouthguard, Over-the-counter Devices (Product Code OBR)

About Product Code OBR - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - OBR Product Code

Related FDA 510(k) Regulatory Insights