Cleared Traditional

K022147 - DENTA PORT (FDA 510(k) Clearance)

K022147 · J. Morita USA, Inc. · Dental device
Dec 2002
Decision
171d
Days
—
Risk

K022147 is an FDA 510(k) clearance for the DENTA PORT. This device is classified as a Locator, Root Apex.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on December 20, 2002, 171 days after receiving the submission on July 2, 2002.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K022147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2002
Decision Date December 20, 2002
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —