SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece— 510(k) K192412

Substantially Equivalent

Dentalez, Inc.

FDA 510(k) clearance K192412 for SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece, Substantially Equivalent on 2020-01-06. Applicant: Dentalez, Inc..

Clearance details

Applicant: Dentalez, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2019-09-04
Decision date: 2020-01-06
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.