Identity
- Trade Name
- Provicol C FDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Device Name
- Provicol C EUDAMEDEugenol-free temporary luting cement with calcium hydroxide. FDA UDI
- Model / Reference
- 1076 EUDAMEDFDA UDI
- Description
- Eugenol-free temporary luting cement with calcium hydroxide. FDA UDI
Identifiers
- Catalog Number
- 1076 FDA UDI
- Primary DI / UDI-DI
- E22110761 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210360010000000BV EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Fatty acid dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Provicol C by VOCO GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E2210360010000000BV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (2)
- EUDAMED 6e614d8d-5080-4157-8d08-5d665840c76f 61 fields · synced Jun 8, 2026
- FDA UDI 3e521e7d-8ffe-4484-a79e-b1fd4668352b 36 fields · synced May 30, 2026