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PrimmaArt
Dentscare Ltda · Model BLEACH 75G · UDI-DI 07899633835331
1
510(k) clearances
122
Adverse events (1 deaths)
4
Recalls
181
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-09 | Talladium Inc | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 ( |
| 2009-10-22 | Jeneric/Pentron | Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in |
| 2004-06-07 | Lang Dental Mfg Co, Inc. | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. |
| 2004-06-07 | Lang Dental Mfg Co, Inc. | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.