Cleared Traditional

COATED APEX PROBE (K890735) - FDA 510(k) Clearance

K890735 · Analytic Technology · Dental device
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Apr 1989
Decision
65d
Days
-
Risk

K890735 is an FDA 510(k) clearance for the COATED APEX PROBE. Classified as Locator, Root Apex (product code LQY).

Submitted by Analytic Technology (Redmond, US). The FDA issued a Cleared decision on April 19, 1989 after a review of 65 days - a notably fast clearance cycle.

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: 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 Analytic Technology devices

Submission Details

510(k) Number K890735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date April 19, 1989
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -