The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for White Core.
| Device ID | K964931 |
| 510k Number | K964931 |
| Device Name: | WHITE CORE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-10 |
| Decision Date | 1997-02-10 |