Ortholux™ Luminous

FDA UDI

Class II (US FDA UDI)

by 3m Unitek Corporation

Identity

Trade Name: Ortholux™ Luminous FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: Ortholux(TM) Luminous Curing Light (USA version) Ea FDA UDI
Model / Reference: 704-460 FDA UDI
Description: Ortholux(TM) Luminous Curing Light (USA version) Ea FDA UDI

Identifiers

Catalog Number: 704-460 FDA UDI
Primary DI / UDI-DI: 00652221149312 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental/surgical polymerization lamp

Ortholux™ Luminous by 3m Unitek Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: 3m Unitek Corporation

Sources (1)

FDA UDI e8970b0f-28f4-4733-8223-84bba58f1565 35 fields · synced May 31, 2026