The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Endo 6:1, T1 Line Endo 6 L, Sironiti Apex, T1 Spray.
| Device ID | K150750 |
| 510k Number | K150750 |
| Device Name: | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | Sirona Dental Systems GMBH Fabrikstrasse 31 Bensheim, DE 64625 |
| Contact | Thomas Diesch |
| Correspondent | Kofi Aninakwa SIRONA DENTAL SYSTEMS, INC. 30-30 47TH AVENUE SUITE 500 Long Island, NY 11101 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-07-02 |
| Summary: | summary |