CETYLITE INDUSTRIES INC

Address:9051 River Rd,PENNSAUKEN,NJ,08110,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

Varnish, Cavity (LBH) (2) Cleaner, Ultrasonic, Medical Instrument (FLG) (1) Sterilant, Medical Devices (MED) (1)

Premarket Exempt

No Yes

Clear

Cetylcide-G - 10631059012217 Catalog Number : 0122

Device Description : Disinfectant-Sterilant

Device Class : 2

Duns Number: 001283704

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

Power Cleaner - 10631059013016 Catalog Number : 0130

Device Description : General purpose ultrasonic cleaning solution

Device Class : 1

Duns Number: 001283704

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Zarosen - 10631059080018 Catalog Number : 0800

Device Description : Cavity varnish

Device Class : 2

Duns Number: 001283704

Premarket Exempt : Yes

Product Code : LBH

Prescription Use : No

Device Count : 1

Varnal - 10631059080117 Catalog Number : 0801

Device Description : Cavity varnish

Device Class : 2

Duns Number: 001283704

Premarket Exempt : Yes

Product Code : LBH

Prescription Use : No

Device Count : 1

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