MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011— 510(k) K051872

Substantially Equivalent

Mk-Dent GmbH

FDA 510(k) clearance K051872 for MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011, Substantially Equivalent on 2005-10-03. Applicant: Mk-Dent GmbH.

Clearance details

Applicant: Mk-Dent GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2005-07-11
Decision date: 2005-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kumhausen, DE

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.