Mark3

FDA UDI

Class II (US FDA UDI)

by Cargus International, Inc

Identity

Trade Name: MARK3 FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Hybrid Composite A3.5 Unidose .25gm. 20/pk. - MARK3 FDA UDI
Model / Reference: 4884 FDA UDI
Description: Hybrid Composite A3.5 Unidose .25gm. 20/pk. - MARK3 FDA UDI

Identifiers

Primary DI / UDI-DI: D79648841 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

Mark3 by Cargus International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cargus International, Inc

Sources (1)

FDA UDI 2546dd24-d108-42b8-9fb5-28ab6482bf73 34 fields · synced Jun 1, 2026