Cleared Traditional

OSADA ENDEX (K904742) - FDA 510(k) Clearance

K904742 · Osada Electric Co., Ltd. · Dental device
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Dec 1990
Decision
60d
Days
-
Risk

K904742 is an FDA 510(k) clearance for the OSADA ENDEX. Classified as Locator, Root Apex (product code LQY).

Submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 60 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 Osada Electric Co., Ltd. devices

Submission Details

510(k) Number K904742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date December 17, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -