The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Simplant Online Case Review And Simplant Editor.
| Device ID | K161118 |
| 510k Number | K161118 |
| Device Name: | SIMPLANT Online Case Review And SIMPLANT Editor |
| Classification | System, Image Processing, Radiological |
| Applicant | DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-20 |
| Decision Date | 2016-07-28 |
| Summary: | summary |