BioSonic US200 Ultrasonic Scaler (60034537)
FDA 510(k) K240801 · Dent4you AG
510(k) numberK240801
Submission
- Device name
- BioSonic US200 Ultrasonic Scaler (60034537)
- Applicant
- Dent4you AG
Heerbrugg, CH - Received
- March 25, 2024
- Decision date
- July 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BioSonic US200 Ultrasonic Scaler (60034537) cleared by the FDA?
BioSonic US200 Ultrasonic Scaler (60034537) (K240801) received a 510(k) decision of Substantially Equivalent on July 1, 2024, 98 days after the submission was received.
What is the product code of K240801?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.