BioSonic US200 Ultrasonic Scaler (60034537)— 510(k) K240801

Name: FDA 510(k) clearance K240801
Creator: U.S. Food and Drug Administration
Published: 2024-07-01

Substantially Equivalent

Dent4you AG

FDA 510(k) clearance K240801 for BioSonic US200 Ultrasonic Scaler (60034537), Substantially Equivalent on 2024-07-01. Applicant: Dent4you AG. Device class: 2.

Clearance details

Applicant: Dent4you AG
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2024-03-25
Decision date: 2024-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heerbrugg, CH

Download summary PDF View on FDA.gov ↗

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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.