Componeer

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: COMPONEER FDA UDI
Generic Name: Dental veneer, professional FDA UDI
Model / Reference: 1378 FDA UDI

Identifiers

Catalog Number: 1378 FDA UDI
Primary DI / UDI-DI: J00613780 FDA UDI
510(k) Number: K112168 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental veneer, professional

Componeer by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental veneer, professional.

crea.lign Dentin A2 — bredent GmbH & Co. KG · Class II
crea.lign incisal E1 — bredent GmbH & Co. KG · Class II
Ceramill — Vertex-Dental B.V. · Class I
Duo:PCH® — Den-Mat Holdings, LLC · Class II
crea.lign Opaker 1 — bredent GmbH & Co. KG · Class II
Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Duo:PCH® — Den-Mat Holdings, LLC · Class II
Vertex-Dental BV — Vertex-Dental B.V. · Class I

Cleared under the same submission

K112168 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Coltène/Whaledent AG

Sources (1)

FDA UDI 956207f3-6224-4ec6-91e0-7a717c534dd1 36 fields · synced May 30, 2026