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DentaTOOTH

ASIGA PTY LTD · Model 03624 · UDI-DI 09359215000109

EBG Prescription

510(k) clearances

122

Adverse events (1 deaths)

Recalls

181

Facilities

Description

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.

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.