PYRAMID

Material, Tooth Shade, Resin

BISCO, INC.

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

Pre-market Notification Details

• Device ID: K982645
• 510k Number: K982645
• Device Name: PYRAMID
• Classification: Material, Tooth Shade, Resin
• Applicant: BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Contact: Kathy Joung
• Correspondent: Kathy Joung; BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-29
• Decision Date: 1998-09-02
• Summary: summary