# K100600: Prosthodontic Screwdriver , Model IA-400

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jul 9, 2010 after 128 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: 2 generations back to K002469 (2001). 4 ancestors in all.
2 later devices descend 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)
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories, W&H Dentalwerk Buermoos GmbH (2006) Summary page 1.
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor, W&H Dentalwerk Buermoos GmbH (2009) Summary page 2.

## Most influential descendants
- K110278: Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900 (2012), 1 descendant of its own
- K161500: Meg-Torq (2017), 0 descendants of its own

## Indications for use
The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1

Source page: https://510kreport.com/device/K100600
Methodology: https://510kreport.com/methodology