ROTARY MASTER

Controller, Foot, Handpiece And Cord

J. MORITA USA, INC.

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

Pre-market Notification Details

• Device ID: K992648
• 510k Number: K992648
• Device Name: ROTARY MASTER
• Classification: Controller, Foot, Handpiece And Cord
• Applicant: J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Product Code: EBW
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-06
• Decision Date: 2000-01-31