HEALTHDENT'L, LLC

Address:10052 BODE ST STE E,Plainfield,IL,60585,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

Agent, Tooth Bonding, Resin (KLE) (2)

Premarket Exempt

Clear

HEMA-BENZ - D799HG100100 Catalog Number : HG10010

Device Description : Fluoride containing dentin cleaning agent to desensitize and clean a prepared to Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior to placement of an amalgam restoration or placement of a crown &/or bridge.

Device Class : 2

Duns Number: 046513054

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

HEMA-GLU - D799HG100200 Catalog Number : HG10020

Device Description : Hema-Glu is a dental desensitizing agent to be placed under dental cements or ot Hema-Glu is a dental desensitizing agent to be placed under dental cements or other restorative materials to desensitize and aid bonding primers in penetrating etched dentin.