Cleared Traditional

LIGHTSPEED DENTAL HAND INSTRUMENT (K932529) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

Device Classification

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.