The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco's Porcelain Veneer System.
| Device ID | K861148 |
| 510k Number | K861148 |
| Device Name: | BISCO'S PORCELAIN VENEER SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 765 SPRINGER DR. Lombard, IL 60148 |
| Contact | Byoung I Suh |
| Correspondent | Byoung I Suh BISCO, INC. 765 SPRINGER DR. Lombard, IL 60148 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-04-30 |