Identity
- Trade Name
- Vertex-Dental BV FDA UDI
- Generic Name
- Dental veneer, professional FDA UDI
- Device Name
- For manufacturing of 3D printed crowns and bridges FDA UDI
- Model / Reference
- NDCMN301000_1 FDA UDI
- Description
- For manufacturing of 3D printed crowns and bridges FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719425508986 FDA UDI
- FDA Product Code
- ELK FDA UDIELJ FDA UDI
- GMDN Term
- Dental veneer, professional FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3910 FDA UDI872.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridgeDental bridge, polymerTemporary dental crown/bridge resinDental prosthesis veneer resin
Vertex-Dental BV by Vertex-Dental B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, polymer.
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- VarseoSmile TriniQ — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG · Class II
- Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vertex-Dental B.V.
Sources (1)
- FDA UDI 7a376c35-529d-4385-86c7-035f1ff9041a 33 fields · synced May 31, 2026