The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Biscem Gi.
| Device ID | K032597 |
| 510k Number | K032597 |
| Device Name: | BISCEM GI |
| Classification | Cement, Dental |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Kathy Joung |
| Correspondent | Kathy Joung BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EMA |
| Subsequent Product Code | DYH |
| Subsequent Product Code | KLE |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-08-22 |
| Decision Date | 2003-11-04 |
| Summary: | summary |