Product code OBR ยท Class U
Mouthguard, Over-The-Counter
5510(k)s in 12 months (47 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OBR
| Company | 510(k)s | Recalls |
|---|---|---|
| Ranir Corporation | 7 | 0 |
| Den Tek Oral Care, Inc. | 6 | 0 |
| Splintek, Inc. | 3 | 0 |
| Boyd Research, Inc. | 2 | 0 |
| Doc Brands, Inc. | 2 | 0 |
| Medtech Products, Inc. | 2 | 0 |
| 1987 Media Limited | 1 | 0 |
| Akervall Technologies, Inc. | 1 | 0 |
| Archtek, Inc. | 1 | 0 |
| ASESSO HEALTH, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K262559 | Mouth Guard ChangSha ChuangDuoLe E-Commerce Co., Ltd., CN | OBR |
| Jun 25, 2026 | K260790 | G-Series Grind Guard ASESSO HEALTH, Inc. | OBR |
| Apr 10, 2026 | K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) 1987 Media Limited, GB | OBR |
| Feb 26, 2026 | K253641 | Owl Night Guard Owl Dental Lab, Inc. | OBR |
| Nov 25, 2025 | K252004 | enCore Night Guard Encore Guards | OBR |
| Oct 17, 2025 | K251778 | Remi Custom Night Guard Remi | OBR |
| May 19, 2025 | K250456 | Dentemp Pro-Comfort Dental Guard Doc Brands, Inc. | OBR |
| May 24, 2024 | K240810 | Anti Grinding Guard Xiamen Yizhou Imp. & Exp. Co., Ltd., CN | OBR |
| Apr 17, 2024 | K232238 | Goyo Mouthpiece S Dimedikorea, KR | OBR |
| Nov 6, 2023 | K231865 | Mouth Guard (ATG0603R) Reazeal Corp | OBR |
| Nov 18, 2022 | K221369 | FBCC Night Guard Fbcc, Inc. | OBR |
| Oct 7, 2022 | K222424 | Protect-It Custom Fit Dental Guard Doc Brands, Inc. | OBR |
| Dec 13, 2021 | K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
| Sep 17, 2021 | K211158 | NTI ClenchGuard Boyd Research, Inc. | OBR |
| Dec 22, 2020 | K202974 | DenTek Fresh Protect Dental Guard Medtech Products, Inc. | OBR |
| Jun 1, 2020 | K193577 | SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
| Jan 15, 2020 | K181005 | ClenchGuard Boyd Research, Inc. | OBR |
| Aug 23, 2019 | K183315 | CustMBite Dental Guard Dental Choice Holdings, LLC | OBR |
| Aug 5, 2019 | K191033 | LunaGuard Nighttime Dental Protector Mckeon Products | OBR |
| Jan 18, 2019 | K181099 | Bright Guard Koncept Innovators, LLC | OBR |
| Sep 17, 2018 | K180933 | DenTek Ultimate Dental Guard Medtech Products, Inc. | OBR |
| Jan 11, 2018 | K172452 | Bruxor Sleep Specialties, LLC | OBR |
| Nov 17, 2017 | K172223 | SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
| Feb 19, 2016 | K150492 | Ora-GUARD Dental Grind Guard Bite Tech, Inc. | OBR |
| Sep 30, 2015 | K151149 | Ready-Fit Den Tek Oral Care, Inc. | OBR |
| Feb 28, 2014 | K132469 | THE BITE GUARD International Profit Builders, Inc. | OBR |
| Jan 23, 2014 | K133037 | GRINDGUARD Grind Guard Technologies, LLC | OBR |
| Dec 20, 2013 | K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR Ranir, LLC | OBR |
| Jan 10, 2013 | K123849 | NEW COMFORT-FIT DENTAL GUARD Den Tek Oral Care, Inc. | OBR |
| Oct 15, 2012 | K121272 | PROTECH DENT Akervall Technologies, Inc. | OBR |
| Jun 27, 2012 | K113326 | ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD Oralabs, Inc. | OBR |
| Feb 3, 2012 | K120103 | REST ASSURED GENERATION III DENTAL PROTECTOR Ranir, LLC | OBR |
| Jan 27, 2012 | K112879 | REST ASSURED READY TO WEAR NITE PROTECTOR Ranir, LLC | OBR |
| Dec 8, 2011 | K111310 | BRUX MOUTHGUARDS Dental Arte, Inc. | OBR |
| Jun 4, 2010 | K100545 | SLEEPRIGHT Power Products, Inc.-Splintek | OBR |
| Jan 25, 2010 | K094020 | GRIND NO MORE GENERATION II Ranir, LLC | OBR |
| Jul 8, 2009 | K091792 | REST ASSURED GENERATION II DENTAL PROTECTOR Ranir Corporation | OBR |
| Jun 12, 2009 | K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 Den Tek Oral Care, Inc. | OBR |
| May 8, 2009 | K091175 | GRIND NO MORE VERSION 2 AND 3 Ranir, LLC | OBR |
| Dec 11, 2008 | K083400 | CUSTOM COMFORT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Oct 6, 2008 | K082301 | GRIND NO MORE Placontrol, Inc. | OBR |
| Jul 10, 2008 | K081669 | IMPROVED COMFORT-FIT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Jul 1, 2008 | K072968 | STRESSGARD NIGHTGUARD Totalgard Corporation | OBR |
| Feb 8, 2008 | K073446 | GRIND GUARD Archtek, Inc. | OBR |
| Dec 19, 2007 | K073220 | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT Prestige Brands, Inc. | OBR |
| Aug 30, 2007 | K072147 | DEN TEK COMFORT FIT NIGHTGUARD Den Tek Oral Care, Inc. | OBR |
| Dec 19, 2006 | K063229 | REST ASSURED NITE PROTECTOR Ranir, LLC | OBR |
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