Concentrix MX-AC High-Speed Handpiece— 510(k) K173465

Substantially Equivalent

Dentalez, Inc.

FDA 510(k) clearance K173465 for Concentrix MX-AC High-Speed Handpiece, Substantially Equivalent on 2018-03-28. Applicant: Dentalez, Inc..

Clearance details

Applicant: Dentalez, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2017-11-08
Decision date: 2018-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, 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.