Mouthguard, Over-The-Counter
FDA product code OBR · Unclassified · Dental
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
46510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Ranir, LLC 7
- Den Tek Oral Care, Inc. 6
- Splintek, Inc. 3
- Doc Brands, Inc. 2
- Boyd Research, Inc. 2
- Medtech Products, Inc. 2
- Power Products, Inc.-Splintek 1
- Dental Arte, Inc. 1
- Oralabs, Inc. 1
- Akervall Technologies, Inc. 1
- Grind Guard Technologies, LLC 1
- International Profit Builders, Inc. 1
- Bite Tech, Inc. 1
- Placontrol, Inc. 1
- Sleep Specialties, LLC 1
- Totalgard Corporation 1
- Koncept Innovators, LLC 1
- Mckeon Products 1
- ASESSO HEALTH, Inc. 1
- Archtek, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260790 | G-Series Grind GuardOBR · Traditional | ASESSO HEALTH, Inc. | 06/25/2026SE |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…OBR · Traditional | 1987 Media Limited | 04/10/2026SE |
| K253641 | Owl Night GuardOBR · Traditional | Owl Dental Lab, Inc. | 02/26/2026SE |
| K252004 | enCore Night GuardOBR · Traditional | Encore Guards | 11/25/2025SE |
| K251778 | Remi Custom Night GuardOBR · Traditional | Remi | 10/17/2025SE |
| K250456 | Dentemp Pro-Comfort Dental GuardOBR · Traditional | Doc Brands, Inc. | 05/19/2025SE |
| K240810 | Anti Grinding GuardOBR · Traditional | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 05/24/2024SE |
| K232238 | Goyo Mouthpiece SOBR · Traditional | Dimedikorea | 04/17/2024SE |
| K231865 | Mouth Guard (ATG0603R)OBR · Traditional | Reazeal Corp | 11/06/2023SE |
| K221369 | FBCC Night GuardOBR · Traditional | Fbcc, Inc. | 11/18/2022SE |
| K222424 | Protect-It Custom Fit Dental GuardOBR · Traditional | Doc Brands, Inc. | 10/07/2022SE |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardOBR · Traditional | Splintek, Inc. | 12/13/2021SE |
| K211158 | NTI ClenchGuardOBR · Traditional | Boyd Research, Inc. | 09/17/2021SE |
| K202974 | DenTek Fresh Protect Dental GuardOBR · Traditional | Medtech Products, Inc. | 12/22/2020SE |
| K193577 | SleepRight ProRx Custom Dental GuardOBR · Traditional | Splintek, Inc. | 06/01/2020SE |
| K181005 | ClenchGuardOBR · Traditional | Boyd Research, Inc. | 01/15/2020SE |
| K183315 | CustMBite Dental GuardOBR · Traditional | Dental Choice Holdings, LLC | 08/23/2019SE |
| K191033 | LunaGuard Nighttime Dental ProtectorOBR · Traditional | Mckeon Products | 08/05/2019SE |
| K181099 | Bright GuardOBR · Traditional | Koncept Innovators, LLC | 01/18/2019SE |
| K180933 | DenTek Ultimate Dental GuardOBR · Traditional | Medtech Products, Inc. | 09/17/2018SE |
| K172452 | BruxorOBR · Traditional | Sleep Specialties, LLC | 01/11/2018SE |
| K172223 | SleepRight ProRx Custom Dental GuardOBR · Traditional | Splintek, Inc. | 11/17/2017SE |
| K150492 | Ora-GUARD Dental Grind GuardOBR · Traditional | Bite Tech, Inc. | 02/19/2016SE |
| K151149 | Ready-FitOBR · Traditional | Den Tek Oral Care, Inc. | 09/30/2015SE |
| K132469 | The Bite GuardOBR · Abbreviated | International Profit Builders, Inc. | 02/28/2014SE |
| K133037 | GrindguardOBR · Traditional | Grind Guard Technologies, LLC | 01/23/2014SE |
| K133423 | Rest Assured Extra Comfort Nite ProtectorOBR · Special | Ranir, LLC | 12/20/2013SE |
| K123849 | New Comfort-Fit Dental GuardOBR · Special | Den Tek Oral Care, Inc. | 01/10/2013SE |
| K121272 | Protech DentOBR · Traditional | Akervall Technologies, Inc. | 10/15/2012SE |
| K113326 | Oral B Plus Outlast Night Time Dental GuardOBR · Traditional | Oralabs, Inc. | 06/27/2012SE |
| K120103 | Rest Assured Generation III Dental ProtectorOBR · Special | Ranir, LLC | 02/03/2012SE |
| K112879 | Rest Assured Ready to Wear Nite ProtectorOBR · Special | Ranir, LLC | 01/27/2012SE |
| K111310 | Brux MouthguardsOBR · Traditional | Dental Arte, Inc. | 12/08/2011SE |
| K100545 | SleeprightOBR · Traditional | Power Products, Inc.-Splintek | 06/04/2010SE |
| K094020 | Grind No More Generation IIOBR · Special | Ranir, LLC | 01/25/2010SE |
| K091792 | Rest Assured Generation II Dental ProtectorOBR · Special | Ranir Corporation | 07/08/2009SE |
| K091660 | Custom Comfort Nightguard Version 2OBR · Special | Den Tek Oral Care, Inc. | 06/12/2009SE |
| K091175 | Grind No More Version 2 and 3OBR · Special | Ranir, LLC | 05/08/2009SE |
| K083400 | Custom Comfort NightguardOBR · Special | Den Tek Oral Care, Inc. | 12/11/2008SE |
| K082301 | Grind No MoreOBR · Traditional | Placontrol, Inc. | 10/06/2008SE |
| K081669 | Improved Comfort-Fit NightguardOBR · Special | Den Tek Oral Care, Inc. | 07/10/2008SE |
| K072968 | Stressgard NightguardOBR · Traditional | Totalgard Corporation | 07/01/2008SE |
| K073446 | Grind GuardOBR · Traditional | Archtek, Inc. | 02/08/2008SE |
| K073220 | The Doctor's Nightguard Advanced ComfortOBR · Special | Prestige Brands, Inc. | 12/19/2007SE |
| K072147 | Den Tek Comfort Fit NightguardOBR · Special | Den Tek Oral Care, Inc. | 08/30/2007SE |
| K063229 | Rest Assured Nite ProtectorOBR · Traditional | Ranir, LLC | 12/19/2006SE |