# K991701: Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma MU (Mini Head), Mach-Sigma SU (STD. Head), Mach-Sigma TU (Torque HD)

- Pathway: 510(k) (Traditional)
- Applicant: Nsk Nakanishi, Inc.
- Decided: Aug 10, 1999 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended for use in general dental applications, where high speed cutting is required, such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings. In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the turbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.

Source page: https://510kreport.com/device/K991701
Methodology: https://510kreport.com/methodology