GC Fuji II LC® 000181Recalls & reported problems
Gc America Inc. · GC Fuji II LC® Core 1-2 Package (1 x 35 g powder, 2 x 5 mL liquid, 1 x scoop, 1 x mixing pad) · 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 D0470001811), received between Dec 7, 2016 and Dec 7, 2016 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INITIAL REPORTER CALLED (B)(4) ON (B)(6) 2016 REGARDING A RASH ON A PATIENT ON THE RIGHT SIDE OF THEIR FACE, ON THE CHEEK FOR 5 YEARS. THE REPORTER STATED THE PATIENT WAS TESTED AND MAY HAVE SENSITIVITY TO METALS. THE REPORTER PROVIDED THE PATIENT'S DENTAL PROVIDER'S INFORMATION. THE REPORTER DID NOT PROVIDE TEST RESULTS. (B)(4) CALLED THE DENTAL PROVIDER ON (B)(4) 2016. THE DENTAL PROFESSIONAL CONFIRMED FUJI II LC CORE, A 3M MANUFACTURED CEMENT, AND A METAL FREE CROWN WAS USED IN 2011 ON THE PATIENT. THE DENTAL PROFESSIONAL STATED THEY SPOKE WITH THE PATIENT ABOUT THEIR CONCERNS AND DID NOT THINK THEY HAD SIGNS OF AN ALLERGY, BUT WOULD CONTINUE TO WORK WITH THE PATIENT AND THEIR ALLERGIST.
Patient problems: Skin Irritation
MAUDE report 6152490 ↗
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- Calibra® Veneer Esthetic Resin Cement 607301Dentsply International Inc. · CEMENT, DENTAL2 reports
- RelyX™ 3525TK3m Company · CEMENT, DENTAL1 report
- RelyX™ 35353m Company · CEMENT, DENTAL1 report
- NexTemp 3001470Premier Dental Products Company · Cement, Dental1 report
- NexTemp 3001471Premier Dental Products Company · Cement, Dental1 report
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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