Prime&Bond active 60667342Recalls & reported problems
Dentsply De Trey GmbH · Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D010606673421), received between Jan 16, 2026 and Jan 16, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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
- Loss of or Failure to Bond9
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095688 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095675 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093323 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093303 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093272 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093213 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093204 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093128 ↗MalfunctionJan 16, 2026Loss of or Failure to Bond
IN THIS EVENT IT IS REPORTED THAT P&BOND ACTIVE ECO REF. THAT WAS USED IN TREATMENT DID NOT BOND. DOCTOR REPORTS DESPITE IDENTICAL PREPARATION WITH STORAGE OF THE ADHESIVE AND USE OF THE PRODUCT THE FILLINGS ARE FAILING AFTER A FEW MONTHS. THERE IS NO ADHESIVE BOND THAT FORMED BETWEEN THE FILLING MATERIAL AND THE DENTIN. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092926 ↗
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 60667341Dentsply De Trey GmbH · AGENT, TOOTH BONDING, RESIN6 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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