The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Core-flo D/c.
| Device ID | K093470 |
| 510k Number | K093470 |
| Device Name: | CORE-FLO D/C |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757A17801S0 | K093470 | 000 |
| 00810111542180 | K093470 | 000 |
| 00810111542203 | K093470 | 000 |
| 00810111542227 | K093470 | 000 |
| 00810111542142 | K093470 | 000 |
| D757A178010 | K093470 | 000 |
| D757A178030 | K093470 | 000 |
| D757A230110 | K093470 | 000 |
| D757A230120 | K093470 | 000 |
| 00810111542166 | K093470 | 000 |