BONAMATES SERIES— 510(k) K040650

Substantially Equivalent

Biotech One, Inc.

FDA 510(k) clearance K040650 for BONAMATES SERIES, Substantially Equivalent on 2004-06-03. Applicant: Biotech One, Inc..

Clearance details

Applicant: Biotech One, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2004-03-11
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.