510(k) K240801
K240801 is an FDA 510(k) premarket notification submitted by Dent4you AG for the device "BioSonic US200 Ultrasonic Scaler (60034537)". The FDA issued a decision of Substantially Equivalent on July 1, 2024. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dent4you AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2024
- Date Received
- March 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type