Cleared Traditional

K050612 - LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE

K050612 is an FDA 510(k) clearance for LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE, manufactured by Lightspeed Technology, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K050612 · Lightspeed Technology, Inc. · Dental device
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May 2005
Decision
55d
Days
Class 1
Risk

K050612 is an FDA 510(k) clearance for the LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Lightspeed Technology, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 55 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 - K050612

510(k) Number K050612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2005
Decision Date May 04, 2005
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

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 88
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K050612.
POWERTOME PERIOTOME
K063007 · Westport Medical, Inc. · Oct 2006
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
TCM ENDO V, MODEL 1534
K042822 · NOUVAG AG · Dec 2004
IMPLANTEO IMPLANTOLOGY MOTOR
K041279 · Anthogyr · Sep 2004
OSSTELL MENTOR RFA
K033689 · Integration Diagnostics, Ltd. · Feb 2004
K050612 · LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
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