MARK3® 5972

by Cargus International, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850014374983 UDI-DI	Date5 Feb 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: MARK3®
Generic name: Dental root surface conditioner
Model / Ref / Catalog: 5972

Primary DI / UDI-DI: 00850014374983
FDA product code: EIC
GMDN term: Dental root surface conditioner

Device class: Class I
Regulation number: 872.4565
GUDID distribution status: In Commercial Distribution

Other devices from Cargus International, Inc

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Class I
MARK3 837-018XC

Class I
MARK3® 5974

Class I
MARK3 6117

Class II
MARK3 6117CS

Class II
MARK3 379-023C

Class I

See all devices from Cargus International, Inc →

Properties

Premarket exempt
Lot / batch number
Expiration date

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Single use: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Manufacturing date: No