Cleared Traditional

K953867 - ROOT CANAL LENGTH MEASURING DEVICE (FDA 510(k) Clearance)

K953867 · J. Morita USA, Inc. · Dental device

Dec 1995

Decision

106d

Days

—

Risk

K953867 is an FDA 510(k) clearance for the ROOT CANAL LENGTH MEASURING DEVICE. This device is classified as a Locator, Root Apex.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 1, 1995, 106 days after receiving the submission on August 17, 1995.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K953867 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 1995
Decision Date	December 01, 1995
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement