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Digital Temp Bleach Single-Unit Capsule 3-Pack

Sprintray, Inc. · Model SRI-0204026 · UDI-DI 00850070544153

EBG Prescription

510(k) clearances

122

Adverse events (1 deaths)

Recalls

181

Facilities

Description

SprintRay Digital Temp is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed temporary full single crowns; temporary partial crowns in anterior and posterior area, individual and fixed single temporary veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

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.