MAJESTIC DRUG CO. INC.

Want to know more about this Organization? Request more information now!

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) (3) Over The Counter Denture Repair Kit (EBO) (1) Reliner, Denture, Over The Counter (EBP) (1) Varnish, Cavity (LBH) (1) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

SenzAway - 00010705400456 Catalog Number :

Device Description : SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and ho SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and hot food and liquids. One application should relieve sensitivity of teeth immediately and will last at least three months (individual results may vary)

Device Class : 2

Duns Number: 001496777

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1

Recapit - 00010705400708 Catalog Number :

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

Device Class : 2

Duns Number: 001496777

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

DenTemp Custom - 00010705400814 Catalog Number :

Device Description : Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementin Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings

Device Class : 1

Duns Number: 001496777

Premarket Exempt : No

Product Code : EMB

Prescription Use : No

Device Count : 1

Dentemp - 00010705400852 Catalog Number :

Device Description : Dentemp is a temporary dental cement for re-cementing loose caps or crowns and r Dentemp is a temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings

Device Class :

Duns Number: 001496777

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Refilit - 00010705400883 Catalog Number :

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

Device Class : 2

Duns Number: 001496777

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

Repair-It - 00010705400913 Catalog Number :

Device Description : Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.

Device Class :

Duns Number: 001496777

Premarket Exempt : Yes

Product Code : EBO

Prescription Use : No

Device Count : 1

Reline-It - 00010705400968 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 :

Duns Number: 001496777

Premarket Exempt : No

Product Code : EBP

Prescription Use : No

Device Count : 1

Previous 1 Next