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Opaquer combo.lign intensiv

FDA UDI

Class II (US FDA UDI)

by bredent GmbH & Co. KG

Identity

Trade Name
Opaquer combo.lign intensiv FDA UDI
Generic Name
Dental veneer, professional FDA UDI
Device Name
Opaquer combo.lign intensiv 4 g FDA UDI
Model / Reference
CO1X4OPI FDA UDI
Description
Opaquer combo.lign intensiv 4 g FDA UDI

Identifiers

Catalog Number
CO1X4OPI FDA UDI
Primary DI / UDI-DI
EBRECO1X4OPI0 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental veneer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental veneer, professional

Opaquer combo.lign intensiv by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental veneer, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
bredent GmbH & Co. KG

Sources (1)

  • FDA UDI a8cc2e34-f38b-4f58-ae19-303418d544d5 35 fields · synced Jun 1, 2026