# K033120: Scaletron Piezo Ultrasound Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International (Suzhou), Ltd.
- Decided: Jan 29, 2004 after 121 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 K014238 (2002). 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)
- K014238: Delsonic 2000, Deldent, Ltd. (2002) Summary page 2.

## Indications for use
The ScaletronTM is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.

Source page: https://510kreport.com/device/K033120
Methodology: https://510kreport.com/methodology