Cleared Traditional

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

Dec 1990
Decision
60d
Days
Risk

K904742 is an FDA 510(k) clearance for the OSADA ENDEX. This device is classified as a Locator, Root Apex.

Submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 17, 1990, 60 days after receiving the submission on October 18, 1990.

This device falls under the Dental FDA review panel.

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

Device Classification

Product Code LQY — Locator, Root Apex
Device Class

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