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 |