HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT— 510(k) K100389

Substantially Equivalent

Handpiece Headquarters

FDA 510(k) clearance K100389 for HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT, Substantially Equivalent on 2010-08-12. Applicant: Handpiece Headquarters.

Clearance details

Applicant: Handpiece Headquarters
Product code: Code EFB
Advisory panel: Dental
Date received: 2010-02-16
Decision date: 2010-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, 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.