Prime&Bond active 60667341Recalls & reported problems
Dentsply De Trey GmbH · Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D010606673411), received between Oct 12, 2023 and Nov 20, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 Incompatibility5
- Device Appears to Trigger Rejection1
Patient problems
- Hypersensitivity/Allergic reaction5
- Burn(s)1
- Burning Sensation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO P&BOND ACTIVE STAND REF. THE PATIENT REPORTED ECZEMA, BUMPS AND OTHER RASHES ON THE SCALP AND BACK. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23604288 ↗InjuryOct 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE STAND.REF. THAT WAS USED IN TREATMENT, THE DENTIST OBSERVED A CHEMICAL BURN ON THE SOFT TISSUE OF A PATIENT AFTER CONTACT. DURATION OF EXPOSURE, EXPOSURE TO OTHER IRRITANTS (E.G. ETCHANT), LOCATION AND SEVERITY OF BURN ARE UNKNOWN. PRODUCT COULD NOT BE RETURNED FOR ANALYSIS.
Patient problems: Burn(s); Hypersensitivity/Allergic reaction
MAUDE report 20535763 ↗InjurySep 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE STAND.REF. HAD COMPLAINTS FROM PATIENTS COMPLAINING ABOUT BURNING SENSATION AND NASTY TASTE, THIS REPORTED BY THE DENTIST. THE OUTCOME OF THESE EVENTS ARE UNKNOWN AS OF THIS MDR AND FURTHER INFORMATION REQUESTED.
Patient problems: Burning Sensation
MAUDE report 20290090 ↗InjuryApr 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION TO P&BOND ACTIVE STAND.REF. THAT WAS USED IN TREATMENT. ADDITIONAL INFORMATION AND PRODUCT HAS BEEN REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19162665 ↗InjuryOct 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT PATIENT EXPERIENCED ALLERGIC REACTION OF THE MUCOSA WITH THE USE OF P&BOND ACTIVE STAND.REF. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17920838 ↗InjuryOct 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT PATIENT HAD A ALLERGIC REACTION OF THE MUCOSA WITH THE USE OF P&BOND ACTIVE STAND. REF. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17920457 ↗
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
- CEREC® Essentials with Celtra® Duo (ZLS) Blocks 61N002Dentsply International Inc. · AGENT, TOOTH BONDING, RESIN2 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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