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Flexcera™ Smile Ultra+ for Carbon® Printers B1

Envisiontec GmbH · Model RES-01-3350 · UDI-DI 04260683220867

EBG PZY ELM EBI EBF Prescription

510(k) clearances

122

Adverse events (1 deaths)

Recalls

183

Facilities

Description

Flexcera™ Smile Ultra+ for Carbon® Printers is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.

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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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.