WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head— 510(k) K160410

Substantially Equivalent

Dental Savings Club

FDA 510(k) clearance K160410 for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head, Substantially Equivalent on 2016-09-29. Applicant: Dental Savings Club.

Clearance details

Applicant: Dental Savings Club
Product code: Code EFB
Advisory panel: Dental
Date received: 2016-02-16
Decision date: 2016-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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.