# K990546: Delsonic 2000

- Pathway: 510(k) (Traditional)
- Applicant: Sds Dental, Inc.
- Decided: Nov 5, 1999 after 256 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dentsply: named in the summary without a submission number

## 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 automatic tuning for each scaling insert.

Source page: https://510kreport.com/device/K990546
Methodology: https://510kreport.com/methodology