Lava™ 3114A2-LTRecalls & reported problems
3m Company · 3M™ ESPE™ Lava™ Ultimate Restorative for E4D™ 14L, shade A2-LT, 3114A2-LT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30605861041233), received between Dec 26, 2018 and Dec 26, 2018 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2018, A DENTIST REPORTED TO 3M THAT SOME OF HIS PATIENTS WHO HAD LAVA ULTIMATE CROWNS PLACED BETWEEN 2012 THROUGH 2015 REQUIRED ROOT CANAL THERAPY BECAUSE OF DECAY BENEATH THE CROWN. THE DENTIST DID NOT PROVIDE A SPECIFIC NUMBER OF CASES THAT HAVE OCCURRED, THE DATES ON WHICH THE ROOT CANALS TOOK PLACE OR OTHER INFORMATION TO ASSIST IN THE INVESTIGATION OF THIS REPORT (SUCH AS THE TYPE OF CEMENT USED TO SEAT THE CROWN). THE DENTIST STATES HE BELIEVES HE FOLLOWED CORRECT PLACEMENT PROTOCOL.
Patient problems: No Code Available
MAUDE report 8197998 ↗InjuryDec 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2018, A DENTIST REPORTED TO 3M THAT SOME OF HIS PATIENTS WHO HAD LAVA ULTIMATE CROWNS PLACED BETWEEN 2012 THROUGH 2015 REQUIRED TOOTH EXTRACTION BECAUSE OF DECAY BENEATH THE CROWN. THE DENTIST DID NOT PROVIDE A SPECIFIC NUMBER OF CASES THAT HAVE OCCURRED, THE DATES ON WHICH THE EXTRACTIONS TOOK PLACE OR OTHER INFORMATION TO ASSIST IN THE INVESTIGATION OF THIS REPORT (SUCH AS THE TYPE OF CEMENT USED TO SEAT THE CROWN). THE DENTIST STATES HE BELIEVES HE FOLLOWED CORRECT PLACEMENT PROTOCOL.
Patient problems: No Code Available
MAUDE report 8197997 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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