The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Biscolor.
Device ID | K875256 |
510k Number | K875256 |
Device Name: | BISCOLOR |
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 | 1987-12-22 |
Decision Date | 1988-02-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D757T140220 | K875256 | 000 |
D757T140210 | K875256 | 000 |
D757T140190 | K875256 | 000 |
D757T140160 | K875256 | 000 |
D757T140140 | K875256 | 000 |
D757T140120 | K875256 | 000 |
D757T140180 | K875256 | 000 |
D757T140170 | K875256 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BISCOLOR 77892391 4042647 Dead/Cancelled |
SAKURA COLOR PRODUCTS CORPORATION 2009-12-14 |