510(k) K032234— MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

Substantially Equivalent

Mk-Dent GmbH

Clearance details

Applicant: Mk-Dent GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2003-07-21
Decision date: 2003-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kumhausen, DE

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.