The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Fluorocore 2.
| Device ID | K083326 |
| 510k Number | K083326 |
| Device Name: | FLUOROCORE 2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-02-10 |
| Summary: | summary |