The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser.
| Device ID | K103753 |
| 510k Number | K103753 |
| Device Name: | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-02-15 |
| Summary: | summary |