ULTRASONIC DENTAL PROPHYLAXIS DEVICE— 510(k) K760805

Substantially Equivalent

Cavitron Corp.

FDA 510(k) clearance K760805 for ULTRASONIC DENTAL PROPHYLAXIS DEVICE, Substantially Equivalent on 1976-10-21. Applicant: Cavitron Corp..

Clearance details

Applicant
Cavitron Corp.
Product code
Code ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

Source: openFDA MAUDE database, through . 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.