SCORPION ULTRASONIC SCALING INSERTS— 510(k) K053578

Substantially Equivalent

Scorpion

FDA 510(k) clearance K053578 for SCORPION ULTRASONIC SCALING INSERTS, Substantially Equivalent on 2006-07-14. Applicant: Scorpion.

Clearance details

Applicant: Scorpion
Product code: Code ELC
Advisory panel: Dental
Date received: 2005-12-22
Decision date: 2006-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

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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.