Identity
- Trade Name
- COMPONEER FDA UDI
- Generic Name
- Dental veneer, professional FDA UDI
- Model / Reference
- 1320 FDA UDI
Identifiers
- Catalog Number
- 1320 FDA UDI
- Primary DI / UDI-DI
- J00613200 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
The COMPONEER is a custom-made dental restoration made of ceramic or polymer-based material (resin) designed to be used in aesthetic dentistry to correct the facial surface of a tooth. It's intended for long-term use via an adhesive and considered single-use.
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:
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
- COMPONEER — Coltène/Whaledent AG
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 1e532260-8444-4d66-a235-946791dcbe9f 36 fields · synced Jul 6, 2026