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