FDA.reportPublic FDA data

DOC BRANDS, INC.

Matched from indexed company URL: DOC Brands

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151282243015128224DOC BRANDS, INC.1Y2026-01-0110334 Cogdill Rd Knoxville TN US 37932
30151282243015128224DOC BRANDS, INC.1Y2020-04-25407 E Lancaster Avenue Wayne PA US 19087

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
00372494101250Dentemp Floss Picks - Dentemp Cool Mint-flavored Floss Picks are plastic handled flossing devices, with floss on one end and an interdental pick on the other. These items are single use and disposable.833-362-2763consumeraffairs@doc-brands.com
00372494101885Refil-it - Refilit is a Eugenol free temporary dental cement for replacing lost fillings.833-362-2763consumeraffairs@doc-brands.com
00372494101915Repair-it - Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks.833-362-2763consumeraffairs@doc-brands.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2231171707366456K964773DENTEMP ONE STEPEMA1997-02-21
3367051707366456K964773DENTEMP ONE STEPEMA1997-02-21
2231171589194432K821581DEN TEMPEMB1982-06-14
3367051589194432K821581DEN TEMPEMB1982-06-14
3367051581214893K250456Dentemp Pro-Comfort Dental GuardOBR2025-05-19
3367052047564943K222424Protect-It Custom Fit Dental GuardOBR2022-10-07
3367051636418787K191618SleepTight Mouthpiece STZLRK2019-12-11
3367051033802255K150492Ora-GUARD Dental Grind GuardOBR2016-02-19
3367051615377373K132506SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASYLRK2014-05-29
2231171882903329K101771RELINE-IT MODEL RELINE-ITEBP2010-09-20
3367051882903329K101771RELINE-IT MODEL RELINE-ITEBP2010-09-20
3367051034591382K024287FIXOBRIDGE 3-CEMENTEMA2003-03-21
2231171081672417
2231171311840609
2231171588886017
2231171798255409
2231171805988797
2231172031325811
3367051102371774
3367051311840609
3367051588886017
3367051798255409
3367051805988797
3367051920027841
3367051984606708
3367052031325811

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBR32025-05-19
EMA32003-03-21
LRK22019-12-11
EBP22010-09-20
EMB21982-06-14

NDC#

PMN#

GUDID#

Reline-it - The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.

Doc Brands, Inc.

2022-03-09