The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Sirolaser Advance+.
| Device ID | K170500 |
| 510k Number | K170500 |
| Device Name: | SIROLaser Advance+ |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Contact | Karl J. Nittinger |
| Correspondent | Karl J. Nittinger Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-05-16 |
| Summary: | summary |