Identity
- Trade Name
- PrimmaArt FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles. FDA UDI
- Model / Reference
- A1 75G FDA UDI
- Description
- PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles. FDA UDI
Identifiers
- Catalog Number
- 4000056635 FDA UDI
- Primary DI / UDI-DI
- 07899633835294 FDA UDI
- 510(k) Number
- FDA Product Code
- EBG FDA 510(k)FDA UDIPOW FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)FDA UDI
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
FDA UDI
PrimmaArt by Dentscare Ltda — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231859 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentscare Ltda
Sources (2)
- FDA 510(k) K231859 24 fields · synced Jun 18, 2026
- FDA UDI 8e22575e-677a-40cb-8fd8-60365028ae8d 35 fields · synced May 27, 2026