# K240801: BioSonic US200 Ultrasonic Scaler (60034537)

- Pathway: 510(k) (Traditional)
- Applicant: Dent4you AG
- Decided: Jul 1, 2024 after 98 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983727 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983727: Biosonic Ultrasonic Scaler System, Coltene/Whaledent, Inc. (1999) Summary page 5.

## Indications for use
Ultrasonic Applications for: - All sub-gingival and supra-gingival scaling and routine prophylaxis procedures. - Periodontal therapy

Source page: https://510kreport.com/device/K240801
Methodology: https://510kreport.com/methodology