PROTECH PROFESSIONAL PRODUCTS INC

PROTECH PROFESSIONAL PRODUCTS INC

Address:2900 Commerce Park Dr Ste 10,BOYNTON BEACH,FL,33426,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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (10)

Premarket Exempt

No Yes

Clear

Permafix - D814FIX11 Catalog Number : FIX1

Device Description : Permafix Full Kit - Permafix cartridge, glaze and catalyst and adhesion promotor

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Permafix - D814FIX21 Catalog Number : FIX2

Device Description : Permafix Relining Cartridge

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Permafix - D814FIX31 Catalog Number : FIX3

Device Description : Permafix Adhesion Promotor

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Permaflex - D814FIX41 Catalog Number : FIX4

Device Description : Permaflex Glaze and Catalyst

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Mollosil Plus Full Kit - D814FIXX11 Catalog Number :

Device Description : Mollosil Plus Full Kit - Mollosil plus cartridge, glaze and catalyst and adhesion promoter

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Molosil Plus Cartridge Only - D814FIXX21 Catalog Number :

Device Description : Mollosil Plus 50 ml cartridge only

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Mollosil Plus Adhesion Promoter - D814FIXX31 Catalog Number :

Device Description : Mollosil Plus Adhesion Promoter 5 ml

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Mollosil Plus Glaze and Catalyst - D814FIXX41 Catalog Number :

Device Description : Mollosil Plue Glaze and Catalyst (2x7ml), Silicone Glaze and Catalyst and Nipples

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ProTech Soft Reline - D814LRC101 Catalog Number : LRC10

Device Description : 60 ml ProTech Soft Reline Self Cure Monomer

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ProTech Soft Reline - D814LRC111 Catalog Number : LRC11

Device Description : 120 ml ProTech Soft Reline Self Cure Monomer

Device Class : 2

Duns Number: 117374900

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

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