The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco Composite.
| Device ID | K940030 |
| 510k Number | K940030 |
| Device Name: | BISCO COMPOSITE |
| Classification | Cement, Dental |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | Kyong O Joung, Ph.d. |
| Correspondent | Kyong O Joung, Ph.d. BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1994-02-04 |