Peak Universal Bond 4554Recalls & reported problems
Ultradent Products, Inc. · Peak Universal Bond Self-Etch Intro Kit · Class 2
All models of Peak Universal Bond (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jun 1, 2022Completed
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Z-1368-2022 · Root cause: Device Design · Recall details · FDA record ↗
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
- 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
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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