Identity
- Trade Name
- Provicol FDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Device Name
- Eugenol-free temporary luting cement with calcium hydroxide. Semi-elastic properties for safe adhesion of the temporary. Calcium hydroxide: supports formation of secondary dentine and is bacteriostatic. Eugenol-free, thus low allergy potential. Ideal before adhesive luting with resin cements, because no inhibition of curing reaction of resin-based filling or luting materials. FDA UDI
- Model / Reference
- 1078 FDA UDI
- Description
- Eugenol-free temporary luting cement with calcium hydroxide. Semi-elastic properties for safe adhesion of the temporary. Calcium hydroxide: supports formation of secondary dentine and is bacteriostatic. Eugenol-free, thus low allergy potential. Ideal before adhesive luting with resin cements, because no inhibition of curing reaction of resin-based filling or luting materials. FDA UDI
Identifiers
- Catalog Number
- 1078 FDA UDI
- Primary DI / UDI-DI
- E22110781 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Fatty acid dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Dimensions & Sizes
- Size
- Weight — 250 Gram FDA UDI
Category: Fatty acid dental cement
Provicol by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI 689b6ec8-03a3-41ec-af38-d9fd434c37d7 36 fields · synced Jun 8, 2026