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) (8) Unit, Operative Dental, Accessories (NRD) (2)

Premarket Exempt

No Yes

Clear

MARK3 - D79603311 Catalog Number : 0331

Device Description : Premium Bite Registration Tray Posterior 50/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 50

MARK3 - D79603321 Catalog Number : 0332

Device Description : Premium Bite Registration Tray Sideless Posterior 50/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 50

MARK3 - D79603331 Catalog Number : 0333

Device Description : Premium Bite Registration Tray Wide Body Posterior 50/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 50

MARK3 - D79603341 Catalog Number : 0334

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

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 35

MARK3 - D796090M1 Catalog Number : 090M

Device Description : Disposable Bib Holders 250/bx. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 250

MARK3 - D796090MCS2 Catalog Number : 090MCS

Device Description : Disposable Bib Holders 20bx./cs. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 20

MARK3 - D79610011 Catalog Number : 1001

Device Description : Disposable Impression Trays #1 Upper Large 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610021 Catalog Number : 1002

Device Description : Disposable Impression Trays #2 Lower Large 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610031 Catalog Number : 1003

Device Description : Disposable Impression Trays #3 Upper Medium 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

MARK3 - D79610041 Catalog Number : 1004

Device Description : Disposable Impression Trays #4 Lower Medium 12/pk. - MARK3®*

Device Class : 1

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 12

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