G-Premio™ BOND 012696Recalls & reported problems
Gc America Inc. · G-Premio™ BOND 5mL Refill · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D0470126961), received between Nov 30, 2020 and Nov 30, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 16, 2026.
Most reported problems
Device problems
- Component Missing1
- Improper Chemical Reaction1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2020Component Missing; Improper Chemical Reaction
GC AMERICA DENTAL DEVICE USED TO BOND TO TOOTH STRUCTURE DOES NOT HAVE ACTIVATING COMPONENT TO ALLOW THE BONDING AGENT TO CURE TO TOOTH OR SUBSEQUENT DENTAL COMPOSITE WHEN EXPOSED TO DENTAL CURING LIGHT. THEREFORE EACH RESTORATIVE PROCEDURE THAT UTILIZED THIS DEFECTIVE PRODUCT OR BONDING AGENT WILL HAVE RESTORATION FAILURE. GC AMERICA SELLS G-PREMIO BOND WHICH HAS NO CAPACITY TO CURE WITH DENTAL LIGHT. SEVERAL LOT NUMBERS FROM GC AMERICA ARE INVOLVED WITH THIS DEFECTIVE PRODUCT. IN ADDITION GC AMERICA HAS ADDITIONAL COMPOSITE RESTORATIVE MATERIAL WHICH ALSO DOES NOT CURE OR HARDEN WHEN EXPOSED TO THE DENTAL CURING LIGHT. THIS COMPOSITE MATERIAL FAILURE WAS REPORTED TO THE MANUFACTURER GC AMERICA IN (B)(6) 2020 AS FORMAL COMPLIANT. UNFORTUNATELY THIS SAME MATERIAL HAD DEFECTIVE QUALITIES IN 2018. THE CURRENT SITUATION WITH THE DEFECTIVE BONDING AGENT FROM GC AMERICA WHICH WAS USED ON HUNDREDS OF OUR DENTAL PATIENTS IN OUR PRACTICE, HAS DRAMATICALLY SHORTENED THE LIFE EXPECTANCY OF SUCH RESTORATIONS IN EACH AND EVERY PATIENT. THESE FAILURES WILL REQUIRE ADDITIONAL DENTAL THERAPY AND MAY CAUSE SIGNIFICANT EXPENSE AND POSSIBLE TOOTH LOSS. ALSO THIS CATASTROPHIC EVENT HAS PLACED MY PROF
Patient problems: Insufficient Information
MAUDE report 10927366 ↗
Other AGENT, TOOTH BONDING, RESIN devices
- Transbond™ Plus 712-0903m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall4 reports
- Peak SE 5135Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond S4554Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond 4541Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Peak Universal Bond 4554Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Transbond™ Plus 712-0913m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall0 reports
- Prime&Bond active 60667342Dentsply De Trey GmbH · AGENT, TOOTH BONDING, RESIN9 reports
- Prime&Bond active 60667341Dentsply De Trey GmbH · AGENT, TOOTH BONDING, RESIN6 reports
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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