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, Impression (ELW) (10)

Premarket Exempt

No Yes

Clear

MARK3 - D796114714 Catalog Number :

Device Description : eXact VPS Impression Material Monophase Fast Set 50ml. Cartridges 4/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961147BULK10 Catalog Number :

Device Description : eXact VPS Impression Material Monophase Fast Set 50ml. Cartridges 180/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D79611501 Catalog Number : 1150

Device Description : eXact VPS 380 Impression Material Heavy Body Regular Set 2/pk. - MARK3®*

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D79611511 Catalog Number : 1151

Device Description : eXact VPS 380 Impression Material Heavy Body Fast Set 2/pk. - MARK3®*

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D79611531 Catalog Number : 1153

Device Description : eXact VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3®*

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 EU - D79611601 Catalog Number :

Device Description : VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 EU

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MARK3 - D796116110 Catalog Number :

Device Description : VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 EU

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MARK3 - D796117010 Catalog Number :

Device Description : Bite Registration Regular Set 2/bx. - MARK3 EU

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 EU - D7961170A0 Catalog Number :

Device Description : Bite Registration Regular Set Cartridge MARK3 EU

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MARK3 - D796117111 Catalog Number :

Device Description : Bite Registration Fast Set 2/bx. - MARK3 EU

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

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