Cleared Traditional

K932529 - LIGHTSPEED DENTAL HAND INSTRUMENT

K932529 is an FDA 510(k) clearance for LIGHTSPEED DENTAL HAND INSTRUMENT, manufactured by Lightspeed Endodontics. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K932529 · Lightspeed Endodontics · Dental device
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Nov 1993
Decision
163d
Days
Class 1
Risk

K932529 is an FDA 510(k) clearance for the LIGHTSPEED DENTAL HAND INSTRUMENT. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Lightspeed Endodontics (Houston, US). The FDA issued a Cleared decision on November 4, 1993 after a review of 163 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lightspeed Endodontics devices

FDA 510(k) Submission Details - K932529

510(k) Number K932529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date November 04, 1993
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 127d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKS File, Pulp Canal, Endodontic

All 10
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K932529.
HERO 642
K970649 · Micro-Mega · May 1997
QUANTEC SERIES 2000 ENDODONTIC FILES
K962031 · Tycom Dental · Jun 1996
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
VISIONER 21-A
K901037 · J. Morita USA, Inc. · Aug 1990
DENTAL INSTRUMENTS - FILES
K823316 · Miltex, Inc. · Nov 1982