# K980162: Mach-Sigma Handpiece, Ultrapush

- Pathway: 510(k) (Traditional)
- Applicant: Nsk Nakanishi, Inc.
- Decided: Jun 5, 1998 after 140 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. This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.

Source page: https://510kreport.com/device/K980162
Methodology: https://510kreport.com/methodology