Doc Brands, Inc.

Address:407 E Lancaster Avenue,Wayne,PA,19087,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cement, Dental (EMA) (2) Denture Repair Kit (EBO) (1) Floss, Dental (JES) (1) Mouthguard, Over-The-Counter (OBR) (1) Reliner, Denture, Over The Counter (EBP) (1) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

Dentemp Floss Picks - 00372494101250 Catalog Number :

Device Description : Dentemp Cool Mint-flavored Floss Picks are plastic handled flossing devices, wit

Device Class : 1

Duns Number: 081254601

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Recap-it - 00372494101700 Catalog Number :

Device Description : Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns.

Device Class : 2

Duns Number: 081254601

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Dentemp - 00372494101854 Catalog Number :

Device Description : Dentemp is composed of zinc oxide-eugenol and intended as an over the counter te

Device Class : 1

Duns Number: 081254601

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

Refil-it - 00372494101885 Catalog Number :

Device Description : Refilit is a Eugenol free temporary dental cement for replacing lost fillings.

Device Class : 2

Duns Number: 081254601

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Repair-it - 00372494101915 Catalog Number :

Device Description : Repair-it is an OTC denture repair kit for home use. The device consists of a ma

Device Class : 2

Duns Number: 081254601

Premarket Exempt : Yes

Product Code : EBO

Prescription Use : No

Device Count : 1

Reline-it - 00372494101960 Catalog Number :

Device Description : The device is a temporary OTC soft, clear denture reliner consisting of 2 parts

Device Class : 2

Duns Number: 081254601

Premarket Exempt : Yes

Product Code : EBP

Prescription Use : No

Device Count : 1

Ora-GUARD - 00816161015131 Catalog Number :

Device Description : Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect

Device Class : U

Duns Number: 081254601

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

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