# OBR · Mouthguard, Over-The-Counter

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/DE-misc/OBR

## Overview

- **Product Code:** OBR
- **Device Name:** Mouthguard, Over-The-Counter
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## 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.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252485](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K252485.md) | ClenchNoMore  (CNM-1 (Mixed sizing)); ClenchNoMore  (CNM-L (Large size)); ClenchNoMore  (CNM-S (Small size)) | 1987 Media Limited | Apr 10, 2026 | SESE |
| [K253641](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K253641.md) | Owl Night Guard | Owl Dental Lab, Inc. | Feb 26, 2026 | SESE |
| [K252004](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K252004.md) | enCore Night Guard | Encore Guards | Nov 25, 2025 | SESE |
| [K251778](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K251778.md) | Remi Custom Night Guard | Remi | Oct 17, 2025 | SESE |
| [K250456](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K250456.md) | Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. | May 19, 2025 | SESE |
| [K240810](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K240810.md) | Anti Grinding Guard | Xiamen Yizhou Imp. & Exp. Co., Ltd. | May 24, 2024 | SESE |
| [K232238](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K232238.md) | Goyo Mouthpiece S | Dimedikorea | Apr 17, 2024 | SESE |
| [K231865](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K231865.md) | Mouth Guard (ATG0603R) | Reazeal Corp | Nov 6, 2023 | SESE |
| [K221369](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K221369.md) | FBCC Night Guard | Fbcc, Inc. | Nov 18, 2022 | SESE |
| [K222424](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K222424.md) | Protect-It Custom Fit Dental Guard | Doc Brands, Inc. | Oct 7, 2022 | SESE |
| [K212706](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K212706.md) | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Splintek, Inc. | Dec 13, 2021 | SESE |
| [K211158](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K211158.md) | NTI ClenchGuard | Boyd Research, Inc. | Sep 17, 2021 | SESE |
| [K202974](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K202974.md) | DenTek Fresh Protect Dental Guard | Medtech Products, Inc. | Dec 22, 2020 | SESE |
| [K193577](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K193577.md) | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | Jun 1, 2020 | SESE |
| [K181005](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K181005.md) | ClenchGuard | Boyd Research, Inc. | Jan 15, 2020 | SESE |
| [K183315](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K183315.md) | CustMBite Dental Guard | Dental Choice Holdings, LLC | Aug 23, 2019 | SESE |
| [K191033](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K191033.md) | LunaGuard Nighttime Dental Protector | Mckeon Products | Aug 5, 2019 | SESE |
| [K181099](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K181099.md) | Bright Guard | Koncept Innovators, LLC | Jan 18, 2019 | SESE |
| [K180933](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K180933.md) | DenTek Ultimate Dental Guard | Medtech Products, Inc. | Sep 17, 2018 | SESE |
| [K172452](https://fda.innolitics.com/submissions/DE/DE-misc/OBR/K172452.md) | Bruxor | Sleep Specialties, LLC | Jan 11, 2018 | SESE |

## Top Applicants

- Den Tek Oral Care, Inc. — 6 clearances
- Ranir, LLC — 6 clearances
- Splintek, Inc. — 3 clearances
- Boyd Research, Inc. — 2 clearances
- Doc Brands, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/DE/DE-misc/OBR](https://fda.innolitics.com/submissions/DE/DE-misc/OBR)

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