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

Material, Tooth Shade, Resin (EBF) (6) Cement, Dental (EMA) (2) Agent, Tooth Bonding, Resin (KLE) (1) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

MARK3 - D79648871 Catalog Number :

Device Description : Hybrid Composite B2 Unidose .25gm. 20/pk. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 20

MARK3 - D79648881 Catalog Number :

Device Description : Hybrid Composite B3 Unidose .25gm. 20/pk. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 20

MARK3 - D79648891 Catalog Number :

Device Description : Hybrid Composite C2 Unidose .25gm. 20/pk. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 20

MARK3 - D796535003 Catalog Number : 5350

Device Description : MARK3 Polycarboxylate Cement 60gm. Powder & 40gm. Liquid

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

MARK3 - D79653511 Catalog Number : 5351

Device Description : Core Build Up Blue Automix Syringe 5ml. 2/bx. + 10 Mixing Tips & Intra-Oral Tips - MARK3®

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 2

MARK3 - D79653521 Catalog Number : 5352

Device Description : Core Build Up White Automix Syringe 5ml. 2/bx. + 10 Mixing Tips & Intra-Oral Tips - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 2

MARK3 - D79653531 Catalog Number : 5353

Device Description : Core Build Up A3 Automix Syringe 5ml. 2/bx. + 10 Mixing Tips & Intra-Oral Tips - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 2

MARK3 - D796536004 Catalog Number : 5360

Device Description : MARK3 Glass Ionomer Luting Cement 100gm. Powder & 60ml. Liquid

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

MARK3 - D79653701 Catalog Number : 5370

Device Description : Reinforced Z.O.E. Cement (IRM) 50gm. Powder 15ml. Liquid - MARK3®

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

MARK3 - D79653851 Catalog Number : 5385

Device Description : Permanent Resin Cement Dual Cure 8gm. Automix Syringe + Mixing Tips - MARK3®

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 2

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