510(k) K090548— CONTRA-ANGLE HANDPIECE KOMET OS30

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

Clearance details

Applicant: W&H Dentalwerk Buermoos GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2009-03-02
Decision date: 2009-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buermoos, AT

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.