OBR — Mouthguard, Over-The-Counter Class U
Classification Details
- Product Code
- OBR
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Unknown
- Implant
- No
Definition
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253641 | owl dental lab | Owl Night Guard | February 26, 2026 |
| K252004 | encore guards | enCore Night Guard | November 25, 2025 |
| K251778 | remi | Remi Custom Night Guard | October 17, 2025 |
| K250456 | doc brands | Dentemp Pro-Comfort Dental Guard | May 19, 2025 |
| K240810 | xiamen yizhou imp. and exp. co | Anti Grinding Guard | May 24, 2024 |
| K232238 | dimedikorea | Goyo Mouthpiece S | April 17, 2024 |
| K231865 | reazeal | Mouth Guard (ATG0603R) | November 6, 2023 |
| K221369 | fbcc | FBCC Night Guard | November 18, 2022 |
| K222424 | doc brands | Protect-It Custom Fit Dental Guard | October 7, 2022 |
| K212706 | splintek | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | December 13, 2021 |
| K211158 | boyd research | NTI ClenchGuard | September 17, 2021 |
| K202974 | medtech products | DenTek Fresh Protect Dental Guard | December 22, 2020 |
| K193577 | splintek | SleepRight ProRx Custom Dental Guard | June 1, 2020 |
| K181005 | boyd research | ClenchGuard | January 15, 2020 |
| K183315 | dental choice holdings | CustMBite Dental Guard | August 23, 2019 |
| K191033 | mckeon products | LunaGuard Nighttime Dental Protector | August 5, 2019 |
| K181099 | koncept innovators | Bright Guard | January 18, 2019 |
| K180933 | medtech products | DenTek Ultimate Dental Guard | September 17, 2018 |
| K172452 | sleep specialties | Bruxor | January 11, 2018 |
| K172223 | splintek | SleepRight ProRx Custom Dental Guard | November 17, 2017 |