# K023697: Steri-Mate Sterilizable Handpiece

- Pathway: 510(k) (Special)
- Applicant: Dentsply International
- Decided: Nov 6, 2002 after 2 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 K941392 (1994). 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)
- K941392: Jet Unit (CJ Handpiece), Dentsply Intl. (1994) Summary page 1.

## Indications for use
Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.

Source page: https://510kreport.com/device/K023697
Methodology: https://510kreport.com/methodology