Identity
- Trade Name
- Profibase FDA UDI
- Generic Name
- Dental base plate FDA UDI
- Device Name
- Profibase is a light-curing resin in pre-contoured plates for maxillae and mandibles for the fabrication of individual impression and functional trays for use in crown, bridge and total prosthetic technique to be used for the fabrication of bases of bite patterns as well as for dimensionally stable base plates for wax contouring in the total prosthetic technique. The material is ready for use and easy to handle. FDA UDI
- Model / Reference
- 2112 FDA UDI
- Description
- Profibase is a light-curing resin in pre-contoured plates for maxillae and mandibles for the fabrication of individual impression and functional trays for use in crown, bridge and total prosthetic technique to be used for the fabrication of bases of bite patterns as well as for dimensionally stable base plates for wax contouring in the total prosthetic technique. The material is ready for use and easy to handle. FDA UDI
Identifiers
- Catalog Number
- 2112 FDA UDI
- Primary DI / UDI-DI
- E22121121 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental base plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
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: Dental base plate
Profibase by VOCO GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI 1097bf67-c45d-4a44-a5f9-d9232fc3c1b8 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026