The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Sirolaser Blue.
| Device ID | K180044 |
| 510k Number | K180044 |
| Device Name: | SIROLaser Blue |
| 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 | 2018-01-08 |
| Decision Date | 2018-03-08 |
| Summary: | summary |