CARGUS INTERNATIONAL, INC

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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) (3)

Premarket Exempt

No Yes

Clear

MARK3 - D79690911 Catalog Number :

Device Description : Etchant Gel 37% Bulk Pack 25/bx. (25x1.2ml. Syr. & 50 Tips) - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 25

MARK3 - D79690921 Catalog Number :

Device Description : Etchant Gel 37% Jumbo Kit 50ml. Syringe(1x50ml. Syr., 4x1.2ml. Empty Syr. & 50 T Etchant Gel 37% Jumbo Kit 50ml. Syringe(1x50ml. Syr., 4x1.2ml. Empty Syr. & 50 Tips) - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

MARK3 - D79690931 Catalog Number : 9093

Device Description : Etchant Gel 37% Jumbo Refill Syringe 50ml. - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 2

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