# K031540: Apex Electric Handpiece System

- Pathway: 510(k) (Traditional)
- Applicant: Lares Research, Inc.
- Decided: Jun 30, 2003 after 45 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 K792159 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984244: Orl-E-92 Surgical Drill System, Bien Air USA, Inc. (1999) Summary page 1.
- K993526: Synea - LS Low-Speed Handpiece, A-Dec, Inc. (2000) Summary page 1.
- K972569: E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation, Nsk Nakanishi, Inc. (1997) Summary page 1.

## Indications for use
The Lares Research Apex” Electric Handpiece System (“System” defined as and limited to: A. Contra Angle Dental Instrument B. Electric Motor and C. Control System) device consists of a dental handpiece and accessories as listed in 21 CFR 872.4200, product code EKX that is a Class I, non-exempt hand-held dental device for dental drilling applications. This device is indicated for use where high speeds are required in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as cutting a tooth for caries, and/or crown preparation and finishing, cutting and/or finishing for dentures, denture bases, crowns, inlays and metal plates and/or root canal preparation for restoration. The device is also indicated for use in difficult to reach areas in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as the preparing dental caries for restorations, and for use at low speeds in teeth cleaning applications and dental surface polishing. The Apex” Electric Handpiece System device is driven by an electronically controlled DC electric motor with a pneurnatic/electronicactuated control system that is connected to the Contra Angle dental instrument via an 180-3964 coupling. The Apex” Electric Handpiece System device is indicated for use by dental professionals only.

Source page: https://510kreport.com/device/K031540
Methodology: https://510kreport.com/methodology