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) (9) Tray, Impression, Preformed (EHY) (1)

Premarket Exempt

No Yes

Clear

MARK3 - D7960221BULK1 Catalog Number :

Device Description : Bite Registration Hard Bite Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602221 Catalog Number :

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

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960222BULK1 Catalog Number :

Device Description : Bite Registration Clear Bite Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602231 Catalog Number :

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

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960223BULK1 Catalog Number :

Device Description : Bite Registration CadCam Bite Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602241 Catalog Number :

Device Description : Bite Registration Mint Chocolate Chip Fast Set 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960224BULK1 Catalog Number :

Device Description : Bite Registration Mint Chocolate Chip Fast Set 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79602251 Catalog Number :

Device Description : Bite Registration Mint Chocolate Chip Super Fast 2/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

MARK3 - D7960225BULK1 Catalog Number :

Device Description : Bite Registration Mint Chocolate Chip Super Fast 100/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 100

MARK3 - D79603301 Catalog Number : 0330

Device Description : Premium Bite Registration Tray Anterior 35/pk. - MARK3®*

Device Class :

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 35

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