The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Tph Spectra St Flowable Composite Restorative.
| Device ID | K182288 |
| 510k Number | K182288 |
| Device Name: | TPH Spectra ST Flowable Composite Restorative |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2018-11-20 |
| Summary: | summary |