Cleared Traditional

K031540 - APEX ELECTRIC HANDPIECE SYSTEM

K031540 is an FDA 510(k) clearance for APEX ELECTRIC HANDPIECE SYSTEM, manufactured by Lares Research, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K031540 · Lares Research, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
45d
Days
Class 1
Risk

K031540 is an FDA 510(k) clearance for the APEX ELECTRIC HANDPIECE SYSTEM. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Lares Research, Inc. (Chico, US). The FDA issued a Cleared decision on June 30, 2003 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031540

510(k) Number K031540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date June 30, 2003
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 128d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

California Department of Health Services
ALFREDO J QUATTRONE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 85
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K031540.
OSSTELL MENTOR RFA
K033689 · Integration Diagnostics, Ltd. · Feb 2004
ATR 5000, LC 5000, IMPLANT SYSTEM
K033597 · Advanced Technology Research (A.T.R.) S.R.L. · Nov 2003
DENTAPORT ZX
K031204 · J. Morita USA, Inc. · Aug 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · Aseptico, Inc. · Mar 2003
POWER DRIVE
K012944 · Mediteam AB · Nov 2001
OSSTELL RESONANCE FREQUENCY ANALYZER
K003714 · Integration Diagnostics, Ltd. · Aug 2001
K031540 · APEX ELECTRIC HANDPIECE SYSTEM
Download PDF FDA Summary Lares Research, Inc.