Cleared Traditional

K090925 - MULTIPLE (APEX LOCATOR), MODEL RCM-7 (FDA 510(k) Clearance)

K090925 · J. Morita USA, Inc. · Dental device
Nov 2009
Decision
235d
Days
—
Risk

K090925 is an FDA 510(k) clearance for the MULTIPLE (APEX LOCATOR), MODEL RCM-7. This device is classified as a Locator, Root Apex.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on November 23, 2009, 235 days after receiving the submission on April 2, 2009.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K090925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date November 23, 2009
Days to Decision 235 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —