FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquira
DI: 07898561546685
·
Model: Surgical Cement Kit (Liquid 20 mL + Powder 50 g)
·
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
- 07898561546685
- Version / Model
- Surgical Cement Kit (Liquid 20 mL + Powder 50 g)
- Catalog Number
- 80322400119
- 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
- 24ae5add-52e6-42f4-9808-1bde63fc122d
Device Description
lt is a surgical cement, to be used after periodontal surgeries, that offers safe local protection for surgical wounds, keeping them clean. lt is obtained by mixing its powder and liquid components. Te product is made of zinc oxide and eugenol and its physical properties make it ideal for use as dressing over wounds, after the surgery. Besides its excellent adhesion and plasticity properties the Surgical Cement is presented in a pinkish coloration, which favors an esthetic result at the wound area.
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 | 07898561546685 | GS1 |