# K110278: Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Feb 15, 2012 after 380 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: 3 generations back to K002469 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100600: Prosthodontic Screwdriver , Model IA-400, W&H Dentalwerk Buermoos GmbH (2010) Summary page 1.

## Most influential descendants
- K161500: Meg-Torq (2017), 0 descendants of its own

## 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/K110278
Methodology: https://510kreport.com/methodology