Mark3

FDA UDI

Class II (US FDA UDI)

by Cargus International, Inc

Identity

Trade Name: MARK3 FDA UDI
Generic Name: Dental impression material adhesive FDA UDI
Device Name: VPS Tray Adhesive 10ml. - MARK3 FDA UDI
Model / Reference: 3000 FDA UDI
Description: VPS Tray Adhesive 10ml. - MARK3 FDA UDI

Identifiers

Primary DI / UDI-DI: D79630001 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Dental impression material adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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 impression material adhesive

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

Similar devices

Also classified as Dental impression material adhesive.

Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
3M™ — 3M Deutschland GmbH · Class I
Affinity™ Tray Adhesive — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
3M™ Impregum™ — 3M Deutschland GmbH · Class I
3M™ — 3M Deutschland GmbH · Class I
COE® Adhesive — Gc America Inc. · Class II
3M™ — 3M Deutschland GmbH · Class I
3M™ ESPE™ Impregum™ — 3M Deutschland GmbH · Class I

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 a3d2b8ad-863f-45ec-904d-d33a60a3d6b1 33 fields · synced May 31, 2026