Crown And Bridge, Temporary, Resin
FDA adverse event reports and recall history for crown and bridge, temporary, resin (product code EBG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 122
- Deaths
- 1
- Injuries
- 100
- Malfunctions
- 10
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-12-03TerminatedEmployee error
TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
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 inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
- 2004-07-20TerminatedOther
Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
- 2004-07-20TerminatedOther
Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
- TerminatedLabeling mix-ups
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
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 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
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