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

Handle, Instrument, Dental (EJB) (5) Material, Impression (ELW) (4) Agent, Tooth Bonding, Resin (KLE) (1)

Premarket Exempt

No Yes

Clear

MARK3 - D79680901 Catalog Number : 8090

Device Description : Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) 400/bx. - MARK3®

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 400

MARK3 - D7968090CS2 Catalog Number : 8090CS

Device Description : Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) 400/bx. 40bx/cs. - MARK3*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 40

MARK3 - D79680951 Catalog Number : 8095

Device Description : Disposable Micro Applicators Fine Assorted Colors (Yellow, Pink) 400/bx. - MARK3®

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 400

MARK3 - D7968095CS2 Catalog Number : 8095CS

Device Description : Disposable Micro Applicators Fine Assorted Colors (Yellow, Pink) 400/bx. 40bx/cs Disposable Micro Applicators Fine Assorted Colors (Yellow, Pink) 400/bx. 40bx/cs. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 40

MARK3 - D79680981 Catalog Number : 8098

Device Description : Disposable Micro Applicators Super Fine White 400/bx. - MARK3®

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 400

MARK3 - D79690101 Catalog Number :

Device Description : Alginate Substitute Fast Set 50ml. Cartridges 8/pk. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 8

MARK3 - D79690121 Catalog Number : 9012

Device Description : Alginate Alternative Fast Set 50ml. Cartridges 8/pk. - MARK3®*

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 8

MARK3 - D79690131 Catalog Number : 9013

Device Description : Alginate Alternative 380 Fast Set 2/pk. - MARK3®*

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D79690211 Catalog Number :

Device Description : Color Changing Alginate Dust-Free Fast Set 1 lb. Bag

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MARK3 - D79690901 Catalog Number :

Device Description : Etchant Gel 37% 4/bx. (4x1.2ml Syr. & 20 Tips) - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 4

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