Cleared Traditional

K071190 - ROOT ZX II (FDA 510(k) Clearance)

K071190 · J. Morita USA, Inc. · Dental device

Aug 2007

Decision

109d

Days

Class 1

Risk

K071190 is an FDA 510(k) clearance for the ROOT ZX II. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 17, 2007, 109 days after receiving the submission on April 30, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K071190 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 2007
Decision Date	August 17, 2007
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF