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

Tray, Impression, Preformed (EHY) (6) Material, Impression (ELW) (4)

Premarket Exempt

No Yes

Clear

MARK3 - D79610051 Catalog Number : 1005

Device Description : Disposable Impression Trays #5 Upper Small 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610061 Catalog Number : 1006

Device Description : Disposable Impression Trays #6 Lower Small 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610071 Catalog Number : 1007

Device Description : Disposable Impression Trays #7 Upper Left - Lower Right 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610081 Catalog Number : 1008

Device Description : Disposable Impression Trays #8 Upper Right - Lower Left 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610091 Catalog Number : 1009

Device Description : Disposable Impression Trays #9 Anterior Upper 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610101 Catalog Number : 1010

Device Description : Disposable Impression Trays #10 Anterior Lower 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79611401 Catalog Number :

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

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

MARK3 - D7961140BULK1 Catalog Number :

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

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

MARK3 - D79611411 Catalog Number :

Device Description : eXact VPS Impression Material Light 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 - D7961141BULK1 Catalog Number :

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

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 180

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