FDA 510(k) Applications for Medical Device Product Code "OBR"
(Mouthguard, Over-The-Counter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K121272 | AKERVALL TECHNOLOGIES INC | PROTECH DENT | 10/15/2012 |
| K073446 | ARCHTEK, INC. | GRIND GUARD | 02/08/2008 |
| K150492 | Bite Tech Inc. | Ora-GUARD Dental Grind Guard | 02/19/2016 |
| K181005 | Boyd Research, Inc. | ClenchGuard | 01/15/2020 |
| K211158 | Boyd Research, Inc. | NTI ClenchGuard | 09/17/2021 |
| K072147 | DEN TEK ORAL CARE, INC. | DEN TEK COMFORT FIT NIGHTGUARD | 08/30/2007 |
| K111310 | DENTAL ARTE, INC. | BRUX MOUTHGUARDS | 12/08/2011 |
| K183315 | Dental Choice Holdings, LLC | CustMBite Dental Guard | 08/23/2019 |
| K083400 | DENTEK ORAL CARE, INC. | CUSTOM COMFORT NIGHTGUARD | 12/11/2008 |
| K091660 | DENTEK ORAL CARE, INC. | CUSTOM COMFORT NIGHTGUARD VERSION 2 | 06/12/2009 |
| K081669 | DENTEK ORAL CARE, INC. | IMPROVED COMFORT-FIT NIGHTGUARD | 07/10/2008 |
| K123849 | DENTEK ORAL CARE, INC. | NEW COMFORT-FIT DENTAL GUARD | 01/10/2013 |
| K151149 | DENTEK ORAL CARE, INC. | Ready-Fit | 09/30/2015 |
| K232238 | Dimedikorea | Goyo Mouthpiece S | 04/17/2024 |
| K250456 | DOC Brands, Inc. | Dentemp Pro-Comfort Dental Guard | 05/19/2025 |
| K222424 | DOC Brands, Inc. | Protect-It Custom Fit Dental Guard | 10/07/2022 |
| K221369 | FBCC Inc | FBCC Night Guard | 11/18/2022 |
| K133037 | GRIND GUARD TECHNOLOGIES, LLC | GRINDGUARD | 01/23/2014 |
| K132469 | INTERNATIONAL PROFIT BUILDERS, INC. | THE BITE GUARD | 02/28/2014 |
| K181099 | Koncept Innovators, LLC. | Bright Guard | 01/18/2019 |
| K191033 | McKeon Products | LunaGuard Nighttime Dental Protector | 08/05/2019 |
| K180933 | Medtech Products Inc. | DenTek Ultimate Dental Guard | 09/17/2018 |
| K202974 | Medtech Products, Inc. | DenTek Fresh Protect Dental Guard | 12/22/2020 |
| K113326 | ORALABS, INC. | ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD | 06/27/2012 |
| K082301 | PLACONTROL INC. | GRIND NO MORE | 10/06/2008 |
| K100545 | POWER PRODUCTS, INC.-SPLINTEK | SLEEPRIGHT | 06/04/2010 |
| K073220 | PRESTIGE BRANDS, INC. | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT | 12/19/2007 |
| K091792 | RANIR CORPORATION | REST ASSURED GENERATION II DENTAL PROTECTOR | 07/08/2009 |
| K094020 | RANIR LLC | GRIND NO MORE GENERATION II | 01/25/2010 |
| K091175 | RANIR LLC | GRIND NO MORE VERSION 2 AND 3 | 05/08/2009 |
| K133423 | RANIR LLC | REST ASSURED EXTRA COMFORT NITE PROTECTOR | 12/20/2013 |
| K120103 | RANIR LLC | REST ASSURED GENERATION III DENTAL PROTECTOR | 02/03/2012 |
| K063229 | RANIR LLC | REST ASSURED NITE PROTECTOR | 12/19/2006 |
| K112879 | RANIR LLC | REST ASSURED READY TO WEAR NITE PROTECTOR | 01/27/2012 |
| K231865 | Reazeal Corp | Mouth Guard (ATG0603R) | 11/06/2023 |
| K172452 | Sleep Specialties, LLC | Bruxor | 01/11/2018 |
| K212706 | Splintek, Inc. | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | 12/13/2021 |
| K172223 | Splintek, Inc. | SleepRight ProRx Custom Dental Guard | 11/17/2017 |
| K193577 | Splintek, Inc. | SleepRight ProRx Custom Dental Guard | 06/01/2020 |
| K072968 | TOTALGARD CORPORATION | STRESSGARD NIGHTGUARD | 07/01/2008 |
| K240810 | Xiamen Yizhou Imp. & Exp. Co., Ltd. | Anti Grinding Guard | 05/24/2024 |
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