TEMPORARY CROWN AND BRIDGE MATERIAL

Crown And Bridge, Temporary, Resin

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Temporary Crown And Bridge Material.

Pre-market Notification Details

• Device ID: K020157
• 510k Number: K020157
• Device Name: TEMPORARY CROWN AND BRIDGE MATERIAL
• Classification: Crown And Bridge, Temporary, Resin
• 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: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-01-17
• Decision Date: 2002-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18522530060235	K020157	000
18522530060228	K020157	000
10852253006233	K020157	000
10852253006226	K020157	000