USI DENTAL SCALER, 25XXX SERIES— 510(k) K062791

Substantially Equivalent

Ultrasonic Services, Inc.

FDA 510(k) clearance K062791 for USI DENTAL SCALER, 25XXX SERIES, Substantially Equivalent on 2006-12-11. Applicant: Ultrasonic Services, Inc..

Clearance details

Applicant
Ultrasonic Services, Inc.
Product code
Code ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, 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.