# K983727: Biosonic Ultrasonic Scaler System

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Jan 20, 1999 after 90 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240801: BioSonic US200 Ultrasonic Scaler (60034537) (2024), 0 descendants of its own

## Indications for use
Ultrasonic applications for - All subgingival and supra gmglval scaling. and routine prophylaxis procedures - Periodontal therapy

Source page: https://510kreport.com/device/K983727
Methodology: https://510kreport.com/methodology