The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Simplant 18.
| Device ID | K172239 |
| 510k Number | K172239 |
| Device Name: | SIMPLANT 18 |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-26 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07392532191251 | K172239 | 000 |
| 07392532191237 | K172239 | 000 |
| 07392532191220 | K172239 | 000 |
| 07392532208416 | K172239 | 000 |
| 07392532206269 | K172239 | 000 |