Dentus Ortholux

FDA UDI

Class I (US FDA UDI)

by Agfa Corp.

Identity

Trade Name: Dentus Ortholux FDA UDI
Generic Name: Dental x-ray film, screen FDA UDI
Model / Reference: DENTUS ORTHOLUX 15X30 FDA UDI

Identifiers

Catalog Number: 39N6N FDA UDI
Primary DI / UDI-DI: 05414904010884 FDA UDI
FDA Product Code: IWZ FDA UDI
GMDN Term: Dental x-ray film, 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

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 15 Centimeter FDA UDI
Width — 30 Centimeter FDA UDI

Category: Dental x-ray film, screen

Dentus Ortholux is a high-quality, single-use dental x-ray film specifically designed for use with dental x-ray systems. With its unique emulsion and sensitive wavelengths, it provides excellent imaging capabilities for dental professionals. This comprehensive image intensifying screen film is ideal for use in clinics, hospitals, and other medical settings where accurate and reliable dental images are crucial.

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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 e5874662-2764-4c93-9555-32779005a770 36 fields · synced Jul 19, 2026