K012060

Substantially Equivalent

MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT

Applicant: Hu-Friedy Mfg. Co., Inc.
Product code: ELC
Advisory panel: Dental
Date received: 2001-07-02
Decision date: 2001-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.