CHARISMA

Material, Tooth Shade, Resin

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Charisma.

Pre-market Notification Details

• Device ID: K910263
• 510k Number: K910263
• Device Name: CHARISMA
• Classification: Material, Tooth Shade, Resin
• Applicant: KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718
• Contact: Sharon Parker
• Correspondent: Sharon Parker; KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-01-22
• Decision Date: 1991-06-03