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Nic Tone, MDC Dental

MDC DENTAL · Model Rapid 67 · UDI-DI 07506338317191

EBG
1
510(k) clearances
122
Adverse events (1 deaths)
4
Recalls
181
Facilities

Description

NIC TONE Rapid Acrylic 67, 90 g

Recalls

DateFirmReason
2020-10-09Talladium IncHeat-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 (
2009-10-22Jeneric/PentronPentron 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
2004-06-07Lang Dental Mfg Co, Inc.The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
2004-06-07Lang Dental Mfg Co, Inc.The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

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Data 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.