The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Tph Spectra+ Universal Composite Restorative.
| Device ID | K162107 |
| 510k Number | K162107 |
| Device Name: | TPH Spectra+ Universal Composite Restorative |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY SIRONA 221 W PHILADELPHIA ST, SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY SIRONA 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 | 2016-07-29 |
| Decision Date | 2016-09-27 |
| Summary: | summary |