Peak Universal BondRecalls & reported problems across all models

We found 3 models of Peak Universal Bond by Ultradent Products, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Peak Universal Bond recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 3 of these models · Recall details · FDA record ↗

Peak Universal Bond models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Peak Universal Bond S4554

  AGENT, TOOTH BONDING, RESIN
  1 recall0 reports
• Peak Universal Bond 4541

  AGENT, TOOTH BONDING, RESIN
  1 recall0 reports
• Peak Universal Bond 4554

  AGENT, TOOTH BONDING, RESIN
  1 recall0 reports

Other Ultradent Products, Inc. products

• Transcend2 models · 0 reports · 2 recalls