430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES— 510(k) K130455

Substantially Equivalent

Dentalez Group, Stardental Division

FDA 510(k) clearance K130455 for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES, Substantially Equivalent on 2013-09-25. Applicant: Dentalez Group, Stardental Division.

Clearance details

Applicant: Dentalez Group, Stardental Division
Product code: Code EFB
Advisory panel: Dental
Date received: 2013-02-22
Decision date: 2013-09-25
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.