510(k) K052334— CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

Substantially Equivalent

Dentsply Intl.

Clearance details

Applicant: Dentsply Intl.
Product code: Code ELC
Advisory panel: Dental
Date received: 2005-08-26
Decision date: 2005-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, 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.