JETLITE

Activator, Ultraviolet, For Polymerization

J. MORITA USA, INC.

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

Pre-market Notification Details

• Device ID: K963110
• 510k Number: K963110
• Device Name: JETLITE
• Classification: Activator, Ultraviolet, For Polymerization
• Applicant: J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Contact: Terry G Mahn
• Correspondent: Terry G Mahn; J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Product Code: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-12
• Decision Date: 1996-10-24