PRIME&BOND XP 60667281Recalls & reported problems
Dentsply De Trey GmbH · PRIME&BOND XP REFILL is a universal Total-Etch Dental Adhesive. Prime&Bond XP Refill is received in a bottle delivery (D010K3027610). With its supporting accessories (Applicator Tips and Clixdish) it can be classified as a convenience kit. · 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 D010606672811), received between Jun 13, 2023 and Feb 6, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility2
Patient problems
- Hypersensitivity/Allergic reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED MILD ALLERGIC REACTION TO THE USE OF PRIME & BOND XP REFILL.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21321900 ↗InjuryJun 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED AN ALLERGIC REACTION TO PRIME & BOND XP REFILL. PATIENT EXPERIENCED BURNING IN THE MOUTH AFTER TREATMENT. THE PATIENT WAS TREATED WITH CORTISONE BY A PHYSICIAN. PATIENT IS SEEKING ADDITIONAL TREATMENT BY A DERMATOLOGIST AND THE OUTCOME OF THIS TREATMENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17117546 ↗
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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