DENTAPORT ZX

Handpiece, Direct Drive, Ac-powered

J. MORITA USA, INC.

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

Pre-market Notification Details

• Device ID: K031204
• 510k Number: K031204
• Device Name: DENTAPORT ZX
• Classification: Handpiece, Direct Drive, Ac-powered
• Applicant: J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005
• Product Code: EKX
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-16
• Decision Date: 2003-08-21
• Summary: summary