Identity
- Trade Name
- Maquira FDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- Provisory is a cement made of zinc oxide and eugenol for temporary fixation of prosthetic pieces. Provisory forms a thin film, with excellent fluidity and high flow, allowing that the restoration is easily set in place. lt presents adequate resistance to support the masticatory loads. lt also presents low solubility to the oral fluids and it is of easy removal when necessary. FDA UDI
- Model / Reference
- Provisory Kit base paste (50 g) + accelerator paste (15 g) + spatulation block FDA UDI
- Description
- Provisory is a cement made of zinc oxide and eugenol for temporary fixation of prosthetic pieces. Provisory forms a thin film, with excellent fluidity and high flow, allowing that the restoration is easily set in place. lt presents adequate resistance to support the masticatory loads. lt also presents low solubility to the oral fluids and it is of easy removal when necessary. FDA UDI
Identifiers
- Catalog Number
- 80322400123 FDA UDI
- Primary DI / UDI-DI
- 07898561542250 FDA UDI
- FDA Product Code
- EMB FDA UDI
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3275 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
Yes
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: Zinc oxide eugenol dental cement
Maquira by Maquira Industria de Produtos Odontologicos S/A — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Zinc oxide eugenol dental cement.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Maquira Industria de Produtos Odontologicos S/A
Sources (1)
- FDA UDI a7c08604-54ff-48b9-952b-64d89dedd1c2 34 fields · synced May 30, 2026