TPH Spectra ST 642475Recalls & reported problems
Dentsply De Trey GmbH · TPH Spectra ST Syringe Refill HV BW is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D0106424751), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Soft/Flexible1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
IN THIS EVENT IT IS REPORTED THAT CERAMX SPECTRA ST SYR HV A3 THAT WAS USED IN TREATMENT, SOME FILLINGS IN A FEW PATIENTS HAVE SOFTENED AND CAN BE REMOVED WITH A HARD INSTRUMENT. WHILE OTHER FILLINGS WITH THE SAME MATERIAL REMAIN UNAFFECTED. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23720057 ↗
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- G-CAM GC00098Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00132Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
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- G-CAM GC00113Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00135Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- PermaFlo 948Ultradent Products, Inc. · MATERIAL, TOOTH SHADE, RESIN1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.