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TERA HARZ

Graphy Inc. · Model TC-80DPA2 · UDI-DI 08800142100116

EBG EBF Prescription

510(k) clearances

122

Adverse events (1 deaths)

Recalls

184

Facilities

Description

TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit

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.