Karlin Dental Distributors Inc

Address:211 Bowes Rd.,Concord Ontario,CA

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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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (5)

Premarket Exempt

Clear

EasySoft Liner Adhesive - 00627843583752 Catalog Number :

Device Class : 2

Duns Number: 243750762

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

EasySoft Liner Starter Kit - 00627843583769 Catalog Number :

Device Description : 2 x 50 ml EasySoft Liner1 x 50 ml EasySoft Liner Sealant1 x 10 ml EasySoft Liner 2 x 50 ml EasySoft Liner1 x 50 ml EasySoft Liner Sealant1 x 10 ml EasySoft Liner Adhesive(mixing tips, brushes, polishing discs and mandrel are all used outside of mouth and are not medical devices)

Device Class : 2

Duns Number: 243750762

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

EasySoft Liner Laboratory Package - 00627843583776 Catalog Number :

Device Description : 4 x 50 ml EasySoft liner2 x 10 ml EasySoft liner adhesive(28 mixing tips that ar 4 x 50 ml EasySoft liner2 x 10 ml EasySoft liner adhesive(28 mixing tips that are only used outside of the mouth and are not medical devices)

Device Class : 2

Duns Number: 243750762

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

EasySoft Liner Sealant - 00627843583783 Catalog Number :

Device Class : 2

Duns Number: 243750762

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

EasySoft Liner Twin Refill Package - 00627843583790 Catalog Number :

Device Description : 2 x 50 ml EasySoft Liner cartridges

Device Class : 2

Duns Number: 243750762

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

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