# K012944: Power Drive

- Pathway: 510(k) (Traditional)
- Applicant: Mediteam AB
- Decided: Nov 20, 2001 after 77 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
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. The FDA summary names no predicate by number.

## Indications for use
The Power drive System is a small battery-powered device, light-weight, low speed electric motor handpiece, runs at 350 rpm to 450 rpm with a maximum torque of 12mNm, and is intended for use in light general dental works where low speed and low torque is required.

Source page: https://510kreport.com/device/K012944
Methodology: https://510kreport.com/methodology