Cefla

FDA UDI

Class I (US FDA UDI)

by DuPhaMed B.V.

Identity

Trade Name: Cefla FDA UDI
Generic Name: Dental x-ray film holder, reusable FDA UDI
Device Name: Positioning rings FDA UDI
Model / Reference: CEF1051 FDA UDI
Description: Positioning rings FDA UDI

Identifiers

Catalog Number: 97901112 FDA UDI
Primary DI / UDI-DI: 08717228440250 FDA UDI
FDA Product Code: EGZ FDA UDI
GMDN Term: Dental x-ray film holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.1905 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental x-ray film holder, reusable

Cefla by DuPhaMed B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental x-ray film holder, reusable.

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TrollByte — Directa AB · Class I
AimRight Holder — SIRONA DENTAL, INC. · Class I
Bar, Alignment, Universal, Short — Dental Imaging Technologies Corporation · Class I
CDR — SIRONA DENTAL, INC. · 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 I	Pending data

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Manufacturer

Manufacturer: DuPhaMed B.V.

Sources (1)

FDA UDI 8939a8d7-7a85-41e1-be34-487bda2ff86f 34 fields · synced Jun 6, 2026