Home › Sprintray, Inc. › Digital Temp - A2 - Multi-Unit Capsule 3-Pack
Digital Temp - A2 - Multi-Unit Capsule 3-Pack
Sprintray, Inc. · Model SRI-0204184 · UDI-DI 00850070544993
EBG
Prescription
1
510(k) clearances
122
Adverse events (1 deaths)
4
Recalls
181
Facilities
Description
SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. 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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Get your free API keyRead the docsData 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.
