Cleared Traditional

ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (K864500) - FDA 510(k) Clearance

K864500 · Analytic Technology · Dental device
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Mar 1987
Decision
125d
Days
-
Risk

K864500 is an FDA 510(k) clearance for the ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001. Classified as Locator, Root Apex (product code LQY).

Submitted by Analytic Technology (Redmond, US). The FDA issued a Cleared decision on March 19, 1987 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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.

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Submission Details

510(k) Number K864500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date March 19, 1987
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -