BISBLOCK

Liner, Cavity, Calcium Hydroxide

BISCO, INC.

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

Pre-market Notification Details

• Device ID: K033521
• 510k Number: K033521
• Device Name: BISBLOCK
• Classification: Liner, Cavity, Calcium Hydroxide
• Applicant: BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Contact: Benjamin Lichtenwalner
• Correspondent: Benjamin Lichtenwalner; BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Product Code: EJK
• CFR Regulation Number: 872.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-07
• Decision Date: 2004-01-16
• Summary: summary