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)
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.

View all Lares Research, Inc. devices

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
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · 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 Peers - EKX Handpiece, Direct Drive, Ac-powered

All 59
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K031540.
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
DENTAPORT ZX
K031204 · J. Morita USA, Inc. · Aug 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · Aseptico, Inc. · Mar 2003
QUANTEC-E ENDO SYSTEM
K990739 · Sybron Dental Specialties, Inc. · May 1999
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
K990682 · Nsk Nakanishi, Inc. · Mar 1999