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RelyX™ 3525TKRecalls & reported problems

3m Company · 3M™ ESPE™ RelyX™ Luting Plus Cement Clicker™ Dispenser Trial Kit, 3525TK · 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 30605861013476), received between Aug 10, 2017 and Aug 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Hole In Material” (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.

Most reported problems

Device problems

  • Hole In Material1
  • Material Perforation1

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.

  • InjuryAug 10, 2017Hole In Material; Material Perforation; Hole In Material; Material Perforation

    ON (B)(6) 2017, 3M WAS NOTIFIED THAT AN (B)(6) YEAR-OLD MALE PATIENT REQUIRED A TOOTH EXTRACTION DUE TO TOOTH DECAY WHICH WAS NOTED AFTER A 3M STAINLESS STEEL CROWN FELL OFF HIS TOOTH. THE STAINLESS STEEL CROWN WAS REPORTED TO HAVE A HOLE IN THE CENTER SURFACE. THE CROWN WAS ORIGINALLY PLACED IN (B)(6)2014 USING 3M ESPE RELYX LUTING PLUS CEMENT.

    Patient problems: No Code Available

    MAUDE report 6786846 ↗

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.