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 |
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 |
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 |