doc-brands.comDentemp Canker Cover
Canker Cover
DOC BRANDS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015128224 | 3015128224 | DOC BRANDS, INC. | 1 | Y | 2026-01-01 | 10334 Cogdill Rd Knoxville TN US 37932 |
| 3015128224 | 3015128224 | DOC BRANDS, INC. | 1 | Y | 2020-04-25 | 407 E Lancaster Avenue Wayne PA US 19087 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00372494101250 | Dentemp 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. | 833-362-2763 | consumeraffairs@doc-brands.com |
| 00372494101700 | Recap-it - Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns. | 833-362-2763 | consumeraffairs@doc-brands.com |
| 00372494101854 | Dentemp - Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings. | 833-362-2763 | consumeraffairs@doc-brands.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 223117 | 1707366456 | K964773 | DENTEMP ONE STEP | EMA | 1997-02-21 |
| 336705 | 1707366456 | K964773 | DENTEMP ONE STEP | EMA | 1997-02-21 |
| 223117 | 1589194432 | K821581 | DEN TEMP | EMB | 1982-06-14 |
| 336705 | 1589194432 | K821581 | DEN TEMP | EMB | 1982-06-14 |
| 336705 | 1581214893 | K250456 | Dentemp Pro-Comfort Dental Guard | OBR | 2025-05-19 |
| 336705 | 2047564943 | K222424 | Protect-It Custom Fit Dental Guard | OBR | 2022-10-07 |
| 336705 | 1636418787 | K191618 | SleepTight Mouthpiece STZ | LRK | 2019-12-11 |
| 336705 | 1033802255 | K150492 | Ora-GUARD Dental Grind Guard | OBR | 2016-02-19 |
| 336705 | 1615377373 | K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY | LRK | 2014-05-29 |
| 223117 | 1882903329 | K101771 | RELINE-IT MODEL RELINE-IT | EBP | 2010-09-20 |
| 336705 | 1882903329 | K101771 | RELINE-IT MODEL RELINE-IT | EBP | 2010-09-20 |
| 336705 | 1034591382 | K024287 | FIXOBRIDGE 3-CEMENT | EMA | 2003-03-21 |
| 223117 | 1081672417 | ||||
| 223117 | 1311840609 | ||||
| 223117 | 1588886017 | ||||
| 223117 | 1798255409 | ||||
| 223117 | 1805988797 | ||||
| 223117 | 2031325811 | ||||
| 336705 | 1102371774 | ||||
| 336705 | 1311840609 | ||||
| 336705 | 1588886017 | ||||
| 336705 | 1798255409 | ||||
| 336705 | 1805988797 | ||||
| 336705 | 1920027841 | ||||
| 336705 | 1984606708 | ||||
| 336705 | 2031325811 |
Product Codes Associated With Registrations#
NDC#
Dentemp Canker Cover
Canker Cover
PMN#
Protect-It Custom Fit Dental Guard
DOC Brands, Inc.
GUDID#
Ora-GUARD - Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
2022-03-09
Dentemp SleepTight - Dentemp SleepTight in an OTC anti-snoring mouthpiece intended for use by adults as an aid to reduce snoring.
2023-01-03
SleepTight Rx - SleepTight Rx is an intramural mandibular advancement device intended to be used for the treatment of snoring and mild to moderate obstructive sleep apnea in adults.
2023-01-03
Dentemp Oral Care Kit - Dentemp Oral Care Kit contains the tools to keep that just from the dentist clean between dental visits. Safely and effectively clean the surface of the teeth with the dental scaler. Remove food particles from between the teeth with the Dental Pick. Use the Tongue Cleaner to help remove the germs that cause bad breath.
2022-11-17
Dentemp 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.
2022-08-22
Recap-it - Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns.
2022-03-09
Dentemp - Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings.
2022-03-09
Refil-it - Refilit is a Eugenol free temporary dental cement for replacing lost fillings.
2022-03-09
Repair-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.
2022-03-09
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.
2022-03-09