# K041755: Cromax High Speed Turbine Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: J.R. Medical Technologies, Inc.
- Decided: Oct 22, 2004 after 115 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: 1 generation back to K972436 (1997). 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)
- K972436: T1 Line Dental Handpieces, Siemens AG (1997) Summary page 1.
- K003518: Rapidd Highspeed Dental Handpiece, Dentsply Intl. (2001) Summary page 1.

## Indications for use
The device is an air-powered dental handpiece for use in general dentistry.

Source page: https://510kreport.com/device/K041755
Methodology: https://510kreport.com/methodology