The following data is part of a premarket notification filed by Dentsply International with the FDA for Quixx Posterior Restorative.
| Device ID | K040144 |
| 510k Number | K040144 |
| Device Name: | QUIXX POSTERIOR RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | P Jeffery Lehn |
| Correspondent | P Jeffery Lehn DENTSPLY INTERNATIONAL 221 WEST 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 | 2004-01-22 |
| Decision Date | 2004-04-01 |
| Summary: | summary |