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Filtek™ 4863B1Recalls & reported problems

3m Company · 3M™ ESPE™ Filtek™ Bulk Fill Restorative Refill, 1 - 4g Syringe - B1, 4863B1 · 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 30605861000414), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017, 3M WAS NOTIFIED THAT A (B)(6) FEMALE PATIENT REQUIRED ROOT CANAL TREATMENT ON TOOTH #28 FOLLOWING A DENTAL TREATMENT WITH 3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE AND 3M ESPE ELIPAR DEEP CURE-S LED CURING LITE.

    Patient problems: No Code Available

    MAUDE report 6723753 ↗

Other MATERIAL, TOOTH SHADE, RESIN devices

All MATERIAL, TOOTH SHADE, RESIN devices →

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