# K082973: Ster-Mate Sterile Lavage Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Jan 29, 2009 after 115 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
The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.

Source page: https://510kreport.com/device/K082973
Methodology: https://510kreport.com/methodology