Caulk® 50% Tooth Conditioner Liquid For Etching Enamel 646009Recalls & reported problems
Dentsply International Inc. · Caulk® 50% Tooth Conditioner Liquid Package, 2 (10ml) bottle Refill · 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 D0026460091), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT TOOTH CONDITIONER WAS DISPENSED EXCESSIVELY IN A PATIENT'S MOUTH COVERING PALLET AND THROAT. THE TOOTH CONDITIONER WAS RINSED THOROUGHLY. PATIENT CONSULTED PHARMACY AND THEY RECOMMENDED BENADRYL AND MAALOX. MATERIAL LEFT OVER WAS THROWN AWAY. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19148582 ↗
Other SEALANT, PIT AND FISSURE, AND CONDITIONER devices
- Clinpro™ 126273m Company · SEALANT, PIT AND FISSURE, AND CONDITIONER1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.