Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OBR · Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
264 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260790 | G-Series Grind Guard | ASESSO HEALTH, Inc. | 2026-06-25 | 106 | 0 |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (La | 1987 Media Limited | 2026-04-10 | 246 | 0 |
| K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026-02-26 | 99 | 0 |
| K252004 | enCore Night Guard | Encore Guards | 2025-11-25 | 151 | 0 |
| K251778 | Remi Custom Night Guard | Remi | 2025-10-17 | 129 | 0 |
| K250456 | Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. | 2025-05-19 | 90 | 0 |
| K240810 | Anti Grinding Guard | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 2024-05-24 | 60 | 0 |
| K232238 | Goyo Mouthpiece S | Dimedikorea | 2024-04-17 | 264 | 0 |
| K231865 | Mouth Guard (ATG0603R) | Reazeal Corp | 2023-11-06 | 133 | 0 |
| K221369 | FBCC Night Guard | Fbcc, Inc. | 2022-11-18 | 190 | 0 |
| K222424 | Protect-It Custom Fit Dental Guard | Doc Brands, Inc. | 2022-10-07 | 57 | 0 |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Cus | Splintek, Inc. | 2021-12-13 | 109 | 0 |
| K211158 | NTI ClenchGuard | Boyd Research, Inc. | 2021-09-17 | 151 | 0 |
| K202974 | DenTek Fresh Protect Dental Guard | Medtech Products, Inc. | 2020-12-22 | 83 | 0 |
| K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020-06-01 | 161 | 0 |
| K181005 | ClenchGuard | Boyd Research, Inc. | 2020-01-15 | 639 | 0 |
| K183315 | CustMBite Dental Guard | Dental Choice Holdings, LLC | 2019-08-23 | 266 | 0 |
| K191033 | LunaGuard Nighttime Dental Protector | Mckeon Products | 2019-08-05 | 109 | 0 |
| K181099 | Bright Guard | Koncept Innovators, LLC | 2019-01-18 | 267 | 0 |
| K180933 | DenTek Ultimate Dental Guard | Medtech Products, Inc. | 2018-09-17 | 160 | 0 |
| K172452 | Bruxor | Sleep Specialties, LLC | 2018-01-11 | 150 | 0 |
| K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017-11-17 | 116 | 0 |
| K150492 | Ora-GUARD Dental Grind Guard | Bite Tech, Inc. | 2016-02-19 | 359 | 0 |
| K151149 | Ready-Fit | Den Tek Oral Care, Inc. | 2015-09-30 | 153 | 0 |
| K132469 | THE BITE GUARD | International Profit Builders, Inc. | 2014-02-28 | 205 | 0 |
| K133037 | GRINDGUARD | Grind Guard Technologies, LLC | 2014-01-23 | 119 | 0 |
| K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR | Ranir, LLC | 2013-12-20 | 42 | 0 |
| K123849 | NEW COMFORT-FIT DENTAL GUARD | Den Tek Oral Care, Inc. | 2013-01-10 | 27 | 0 |
| K121272 | PROTECH DENT | Akervall Technologies, Inc. | 2012-10-15 | 171 | 0 |
| K113326 | ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD | Oralabs, Inc. | 2012-06-27 | 230 | 0 |
| K120103 | REST ASSURED GENERATION III DENTAL PROTECTOR | Ranir, LLC | 2012-02-03 | 22 | 0 |
| K112879 | REST ASSURED READY TO WEAR NITE PROTECTOR | Ranir, LLC | 2012-01-27 | 119 | 0 |
| K111310 | BRUX MOUTHGUARDS | Dental Arte, Inc. | 2011-12-08 | 212 | 0 |
| K100545 | SLEEPRIGHT | Power Products, Inc.-Splintek | 2010-06-04 | 98 | 0 |
| K094020 | GRIND NO MORE GENERATION II | Ranir, LLC | 2010-01-25 | 27 | 0 |
| K091792 | REST ASSURED GENERATION II DENTAL PROTECTOR | Ranir Corporation | 2009-07-08 | 21 | 0 |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | Den Tek Oral Care, Inc. | 2009-06-12 | 3 | 0 |
| K091175 | GRIND NO MORE VERSION 2 AND 3 | Ranir, LLC | 2009-05-08 | 16 | 0 |
| K083400 | CUSTOM COMFORT NIGHTGUARD | Den Tek Oral Care, Inc. | 2008-12-11 | 24 | 0 |
| K082301 | GRIND NO MORE | Placontrol, Inc. | 2008-10-06 | 55 | 0 |
| K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | Den Tek Oral Care, Inc. | 2008-07-10 | 27 | 0 |
| K072968 | STRESSGARD NIGHTGUARD | Totalgard Corporation | 2008-07-01 | 253 | 0 |
| K073446 | GRIND GUARD | Archtek, Inc. | 2008-02-08 | 63 | 0 |
| K073220 | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT | Prestige Brands, Inc. | 2007-12-19 | 34 | 0 |
| K072147 | DEN TEK COMFORT FIT NIGHTGUARD | Den Tek Oral Care, Inc. | 2007-08-30 | 27 | 0 |
| K063229 | REST ASSURED NITE PROTECTOR | Ranir, LLC | 2006-12-19 | 55 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda