510(k) · Cleared
ClearedApex Electric Handpiece System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lares Research, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jun 30, 2003 as substantially equivalent to K984244 (Bien Air USA, Inc., 1999) and 2 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Jun 30, 2003
- Review
- 45 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792159 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792159 | Fisch Drill System | Jedmed Instrument Co. | 1979 | 1 |
| −1 | K984244 | Orl-E-92 Surgical Drill System | Bien Air USA, Inc. | 1999 | — |
| 0 (this device) | K031540 | Apex Electric Handpiece System | Lares Research, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984244 | Orl-E-92 Surgical Drill SystemSummary page 1…ny Device 510(k) No. Date Cleared Bien Air USA, Inc. ORL-E-92 Surgical Drill System K984244 02/23/1999 W&H Synea WA-99LT K993526 01111/2000 NSK… | 1999 |
| * | K993526 | Synea - LS Low-Speed HandpieceSummary page 1…n Air USA, Inc. ORL-E-92 Surgical Drill System K984244 02/23/1999 W&H Synea WA-99LT K993526 01111/2000 NSK Speed Increaser Contra Angle K972569 10/08/1997 The ApexTMElectric… | 2000 |
| * | K972569 | E-Type Speed Increaser Contra Angle, External Irrigation, Internal IrrigationSummary page 1…W&H Synea WA-99LT K993526 01111/2000 NSK Speed Increaser Contra Angle K972569 10/08/1997 The ApexTMElectric Handpiece System is a pneumatic/electronic controlled drive for dental drilling applications.… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 19.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (215 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031540: Apex Electric Handpiece System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031540
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026