BioSonic US200 Ultrasonic Scaler (60034537)— 510(k) K240801
Substantially EquivalentDent4you AG
FDA 510(k) clearance K240801 for BioSonic US200 Ultrasonic Scaler (60034537), Substantially Equivalent on 2024-07-01. Applicant: Dent4you AG.
Clearance details
- Applicant
- Dent4you AG
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heerbrugg, CH
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.