# K192412: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez, Inc.
- Decided: Jan 6, 2020 after 124 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K902402 (1990). 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)
- K153411: 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece, Dentalez, Inc. (2016) Summary page 4.

## Indications for use
The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

Source page: https://510kreport.com/device/K192412
Methodology: https://510kreport.com/methodology