# K161500: Meg-Torq

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Nx Co., Ltd.
- Decided: Feb 22, 2017 after 266 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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: 4 generations back to K002469 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110278: Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900, Nakanishi, Inc. (2012) Summary page 4.

## Indications for use
This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

Source page: https://510kreport.com/device/K161500
Methodology: https://510kreport.com/methodology