FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquira
DI: 07898561542250
·
Model: Provisory Kit base paste (50 g) + accelerator paste (15 g) + spatulation block
·
Maquira Industria de Produtos Odontologicos S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Maquira
- Primary DI
- 07898561542250
- Version / Model
- Provisory Kit base paste (50 g) + accelerator paste (15 g) + spatulation block
- Catalog Number
- 80322400123
- Company Name
- Maquira Industria de Produtos Odontologicos S/A
- Labeler DUNS
- 679266866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-07
- Public Version
- 3
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- a7c08604-54ff-48b9-952b-64d89dedd1c2
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMB | Zinc Oxide Eugenol | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62200 | Zinc oxide eugenol dental cement | A non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components (e.g., rosin/colophony). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898561542250 | GS1 |