510(k) K021253— ULTRASONIC TIPS WITH DIAMOND COATING

Substantially Equivalent

Sybron Endo/Analytic

Clearance details

Applicant: Sybron Endo/Analytic
Product code: Code ELC
Advisory panel: Dental
Date received: 2002-04-19
Decision date: 2002-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, 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.