OBR

Product Code: OBR


Products Classified as OBR

1420Mouthguard, Over-the-counter

Total Product Life Cycle (TPLC) Devices

1420Mouthguard, Over-the-counter

FDA Consensus Standards

Mouthguard, Over-The-Counter [35851]21 CFR Unclassified 🔎
Mouthguard, Over-The-Counter [38733]21 CFR Unclassified 🔎
Mouthguard, Over-The-Counter [35869]21 CFR Unclassified 🔎

Pre-market Notifications for OBR

K222424Protect-It Custom Fit Dental GuardDOC Brands, Inc.
K221369FBCC Night GuardFBCC Inc
K211158NTI ClenchGuardBoyd Research, Inc.
K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.
K191033LunaGuard Nighttime Dental ProtectorMcKeon Products
K183315CustMBite Dental GuardDental Choice Holdings, LLC
K181099Bright GuardKoncept Innovators, LLC.
K181005ClenchGuardBoyd Research, Inc.
K180933DenTek Ultimate Dental GuardMedtech Products Inc.
K172452BruxorSleep Specialties, LLC
K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.
K151149Ready-FitDENTEK ORAL CARE, INC.
K150492Ora-GUARD Dental Grind GuardBite Tech Inc.
K133423REST ASSURED EXTRA COMFORT NITE PROTECTORRANIR LLC
K133037GRINDGUARDGRIND GUARD TECHNOLOGIES, LLC

Global Unique Device Identification Database

10041260371469Mouthguard, Over-The-Counter
20681131135607Mouthguard, Over-The-Counter
10036800410302Mouthguard, Over-The-Counter
80011822768869Mouthguard, Over-The-Counter
80719283190396Mouthguard, Over-The-Counter
30047701004655Mouthguard, Over-The-Counter
40047701001514Mouthguard, Over-The-Counter
30050428538082Mouthguard, Over-The-Counter
30050428373263Mouthguard, Over-The-Counter
30050428269870Mouthguard, Over-The-Counter
00311917190143Mouthguard, Over-The-Counter
10866330000205Mouthguard, Over-The-Counter
08711744032579Mouthguard, Over-The-Counter
27392222170508Mouthguard, Over-The-Counter
10047701000417Mouthguard, Over-The-Counter

Maude Adverse Events

EQUATE MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2020-03-20
LIFE BRAND MTH GD RST ASRD W/TRAYRANIR LLC2020-02-21
PLACKERS MTH GD GNM 10CTRANIR LLC2020-02-06
REXALLRANIR LLC2020-01-09
PLACKERS MTH GD GNM 14RANIR LLC2019-10-03
PLACKERS MTH GD GNM 16CTRANIR LLC2019-09-26
KROGER MTH GD RST ASRD W/TRAY 2CTRANIR LLC2019-09-12
KROGER MTH GD RST ASRD W/TRAYRANIR LLC2019-09-12
REST ASSUREDW/TRAYRANIR LLC2019-09-04
PLACKERS MTH GD STP GRNDNG 1CTRANIR LLC2019-08-14
EQUATE MTH GD RST ASRD W/TRAYRANIR LLC2019-07-10
PLACKERS STOP GRINDING 1CTRANIR LLC2019-05-28
EQUATE MTH GD RST ASRD W/TRAYRANIR LLC2019-04-23
RITE AID REST ASSURED NITERANIR LLC2019-04-22
CVS REST ASSURED GEN. IIRANIR LLC2019-04-18
PLACKERS MTH GD GNMRANIR LLC2019-04-17
PLACKERS MTH GD GNMRANIR LLC2019-04-15
LIFE BRAND MTH GD RST ASRD W/TRAY CRTNRANIR LLC2019-03-15
LIFE BRAND MTH GD RST ASRD W/TRAY CRTNRANIR LLC2019-03-15
PLACKERS MTH GD GNMRANIR LLC2019-03-08
PLACKERS MTH GD GNMRANIR LLC2019-03-04
EQUATE MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2019-03-01
EQUATE MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2019-03-01
PLACKERS STOP GRINDINGRANIR LLC2019-02-28
DENTEK MAXIMUM PROTECTION DENTAL GUARDDENTEK ORAL CARE, INC2019-02-21
EQUATE MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2019-02-06
EQUATE MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2019-01-31
UNKNOWNRANIR LLC2019-01-30
LIFE BRANDRANIR LLC2019-01-29
DENTEK MAXIUMUM PROTECTION DENTAL GUARDPRESTIGE BRANDS INC.2019-01-10
EQUATERANIR LLC2018-12-21
UP&UP MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2018-11-30
EQUATE MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-11-28
KROGER MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-11-02
RITE AID MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-10-30
UP&UP MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-10-30
EQUATE MTH GD RST ASRD W/TRAYRANIR LLC2018-10-05
PLACKERS MTH GD GNM 10CTRANIR LLC2018-09-27
UP&UP MTH GD RST ASRD W/TRAY 2CT CDRANIR LLC2018-09-19
LIFE BRAND MTH GD RST ASRD W/TRAY CRTNRANIR LLC2018-09-19
EQUATE MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-08-02
MEIJER MTH GD RST ASRD EX COMF 2CTRANIR LLC2018-08-01
EQUATE MTH GD RST ASRD W/TRAYRANIR LLC2018-07-23
EQUATE MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-06-26
LIFE BRANDRANIR LLC2018-06-20
RITE AID MTH GD RST ASRD W/TRAY 2CTRANIR LLC2018-06-12
EQUATE MTH GD RST ASRD W/TRAYRANIR LLC2018-05-25
RITE AID MTH GD RST ASRD W/TRAY 2CT CRTNRANIR LLC2018-05-22
RITE AID MTH GD RST ASRD W/TRAY 2CT CRTNRANIR LLC2018-05-22
GRIND GUARD MTH GD RST ASRD W/TRAY CRTNRANIR LLC2018-05-03

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