Cleared Traditional

K921979 - ROOT ZX (FDA 510(k) Clearance)

K921979 · J. Morita USA, Inc. · Dental device
May 1993
Decision
394d
Days
—
Risk

K921979 is an FDA 510(k) clearance for the ROOT ZX. This device is classified as a Locator, Root Apex.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on May 27, 1993, 394 days after receiving the submission on April 28, 1992.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K921979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date May 27, 1993
Days to Decision 394 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —