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 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.

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 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.

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 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.

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 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.

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 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.

Device Class : U

Duns Number: 081254601

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

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