# K014238: Delsonic 2000

- Pathway: 510(k) (Traditional)
- Applicant: Deldent, Ltd.
- Decided: Jan 24, 2002 after 29 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
- K033120: Scaletron Piezo Ultrasound Scaler (2004), 0 descendants of its own

## Indications for use
The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system provides for automatic tuning for each scaling insert.

Source page: https://510kreport.com/device/K014238
Methodology: https://510kreport.com/methodology