The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012.
| Device ID | K082449 |
| 510k Number | K082449 |
| Device Name: | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
| Classification | Cement, Dental |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-25 |
| Decision Date | 2008-09-25 |
| Summary: | summary |