DeviceClearance

K240801

Substantially Equivalent

BioSonic US200 Ultrasonic Scaler (60034537)

Applicant
Dent4you AG
Product code
ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Heerbrugg, CH
Download summary PDF View 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.