FDA.reportPublic FDA data

DenTek Oral Care, Inc.

Matched from indexed company URL: DENTEK CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29383862938386DenTek Oral Care, Inc.1Y2026-01-01660 white plains rd -- Tarrytown NY US 10591

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00047701000557Dentek - DNTK FRSH PROTECT 32CT GRD 12800-433-6835xx@xx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2260951428745436K202974DenTek Fresh Protect Dental GuardOBR2020-12-22
2260951770415682K183436OraCureOLR2019-09-18
2260952054848137K180933DenTek Ultimate Dental GuardOBR2018-09-17
2260951774534987K151149Ready-FitOBR2015-09-30
2260952046584434K130186DENTEK EASY BRUSH WITH FLUORIDEEFW2013-07-15
2260951780133297K123849NEW COMFORT-FIT DENTAL GUARDOBR2013-01-10
2260951014155458K122663ORAMOISTLFD2013-05-30
2260951529639877K120109SUPER SEAL TOOTH DESENSITIZERLBH2012-03-07
2260951498579867K091660CUSTOM COMFORT NIGHTGUARD VERSION 2OBR2009-06-12
2260951588769699K083400CUSTOM COMFORT NIGHTGUARDOBR2008-12-11
2260951110200933K081669IMPROVED COMFORT-FIT NIGHTGUARDOBR2008-07-10
2260951186394511
2260951021460111
2260951133733251
2260951284787251
2260951329892298
2260951350869230
2260951381934653
2260951401536561
2260951936940245
2260952043953421

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBR72020-12-22
OLR12019-09-18
EFW12013-07-15
LFD12013-05-30
LBH12012-03-07

NDC#

PMN#

GUDID#

46 records. Showing 1-40. Next