CRISTOBAL

Material, Tooth Shade, Resin

NEWAVE MEDICAL, INC.

The following data is part of a premarket notification filed by Newave Medical, Inc. with the FDA for Cristobal.

Pre-market Notification Details

• Device ID: K980018
• 510k Number: K980018
• Device Name: CRISTOBAL
• Classification: Material, Tooth Shade, Resin
• Applicant: NEWAVE MEDICAL, INC. 70 WALNUT ST. Wellesley, MA 02181
• Contact: Jean-luc Boulnois
• Correspondent: Jean-luc Boulnois; NEWAVE MEDICAL, INC. 70 WALNUT ST. Wellesley, MA 02181
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-02
• Decision Date: 1998-05-19
• Summary: summary