Dentus M2 Comfort

FDA UDI

Class I (US FDA UDI)

by Agfa Corp.

Identity

Trade Name: Dentus M2 Comfort FDA UDI
Generic Name: Dental x-ray film, non-screen FDA UDI
Model / Reference: DENTUS M2 COMFORT 3x4cm FDA UDI

Identifiers

Catalog Number: 34HLM FDA UDI
Primary DI / UDI-DI: 05414904038802 FDA UDI
FDA Product Code: IWZ FDA UDI
GMDN Term: Dental x-ray film, non-screen FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1840 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 3 Centimeter FDA UDI
Width — 4 Centimeter FDA UDI

Category: Dental x-ray film, non-screen

Dentus M2 Comfort by Agfa Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Henry Schein — HENRY SCHEIN, INC. · Class I
DV-57 ADULT TWIN VALUE PAK — Flow X-Ray Corp. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
BUTTERFLY BARRIER FILM FSS-54 — Flow X-Ray Corp. · 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 I	Pending data

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Manufacturer

Manufacturer: Agfa Corp.

Sources (1)

FDA UDI c4f2c9f9-b432-470e-b4aa-29ceeb2e4111 36 fields · synced Jun 1, 2026