# K070307: Steri -Mate Handpiece Sleeve with Led Light

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: May 2, 2007 after 90 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: 2 generations back to K913724 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041392: Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US, CAO Group, Inc. (2004)

## Indications for use
The Steri-Mate Handpiece Sleeve with LED Light is indicated for: 1. Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece. 2. When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinician comfort. 3. The Steri-Mate handpiece with the lighted sleeve is steam sterilizeable which reduces the risk of cross contamination.

Source page: https://510kreport.com/device/K070307
Methodology: https://510kreport.com/methodology