SureFil® SDR® flow+ Bulk Fill Flowable 61C101Recalls & reported problems
Dentsply International Inc. · SureFil® SDR® flow+ Compula® Tips Refill Package - Universal Shade · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 D00261C1011), received between Jun 11, 2024 and Jun 11, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.
InjuryJun 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION WHEN SURFL SDR FLOW+ CMPL REF UNIV WAS USED IN TREATMENT. THE SDR FLOW WAS USED TO CEMENT A TITANIUM RETAINER AFTER INVISALIGN AND THE PATIENT HAD A REACTION TO THE SDR FLOW. THE PATIENT WENT TO AN ALLERGIST FOR TESTING AND FOUND TO BE ALLERGIC TO SOMETHING IN THE SDR. DOCTOR TO COMPLETE CHECKLIST QUESTIONNAIRE, AWAITING FOR FURTHER INFORMATION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19514978 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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