#8C RENEGADE DENTAL HANDPIECE— 510(k) K142063

Substantially Equivalent

Handpiece Club, LLC

FDA 510(k) clearance K142063 for #8C RENEGADE DENTAL HANDPIECE, Substantially Equivalent on 2014-10-28. Applicant: Handpiece Club, LLC.

Clearance details

Applicant: Handpiece Club, LLC
Product code: Code EFB
Advisory panel: Dental
Date received: 2014-07-30
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, 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.