FORTIFY

Material, Tooth Shade, Resin

BISCO, INC.

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

Pre-market Notification Details

• Device ID: K882915
• 510k Number: K882915
• Device Name: FORTIFY
• Classification: Material, Tooth Shade, Resin
• Applicant: BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409
• Contact: Byoung I Suh
• Correspondent: Byoung I Suh; BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-07-12
• Decision Date: 1988-08-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D757G9310S0	K882915	000
D757G93100	K882915	000
D757G93020	K882915	000
D757G9301F1	K882915	000
00810111542388	K882915	000