The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sirolaser Advance.
| Device ID | K092660 |
| 510k Number | K092660 |
| Device Name: | SIROLASER ADVANCE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2009-12-03 |
| Summary: | summary |