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Calibra® Veneer Esthetic Resin Cement 607301Recalls & reported problems

Dentsply International Inc. · Calibra® Veneer Cement, Try-In Paste Refill Package, Light, 2 syringe (1.8g) · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D0026073011), received between Jun 23, 2023 and Jun 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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.

Most reported problems

Device problems

  • Patient-Device Incompatibility2

Patient problems

  • Hypersensitivity/Allergic reaction2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    IN THIS EVENT IT IS REPORTED THAT CALIBRA VEN TRY-IN 1.8GM LT RF THAT WAS USED ALLEGEDLY CAUSED A IRRIATIATION REACTION TO A PATIENT. NO INJURY REPORTED. FURTHER INFORMATION REQUESTED.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 17194487 ↗
  • MalfunctionJun 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    IN THIS EVENT IT IS REPORTED THAT CALIBRA VEN TRY-IN 1.8GM LT RF THAT WAS USED ALLEGEDLY CAUSED A IRRIATIATION REACTION TO A PATIENT. NO INJURY REPORTED. FURTHER INFORMATION REQUESTED.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 17194364 ↗

Other CEMENT, DENTAL devices

All CEMENT, DENTAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.