EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400— 510(k) K112869

Substantially Equivalent

Beyes Dental Canada, Inc.

FDA 510(k) clearance K112869 for EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400, Substantially Equivalent on 2011-12-16. Applicant: Beyes Dental Canada, Inc..

Clearance details

Applicant: Beyes Dental Canada, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2011-09-30
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.