The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dyract Extra Restorative.
| Device ID | K050880 |
| 510k Number | K050880 |
| Device Name: | DYRACT EXTRA RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-06 |
| Decision Date | 2005-04-22 |
| Summary: | summary |