ROOT ZX

Locator, Root Apex

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Root Zx.

Pre-market Notification Details

• Device ID: K921979
• 510k Number: K921979
• Device Name: ROOT ZX
• Classification: Locator, Root Apex
• Applicant: J. MORITA USA, INC. 9 MASON Irvine, CA 92618
• Contact: Ronald D Newman
• Correspondent: Ronald D Newman; J. MORITA USA, INC. 9 MASON Irvine, CA 92618
• Product Code: LQY
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-28
• Decision Date: 1993-05-27