The following data is part of a premarket notification filed by Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St with the FDA for Nucleoss T6 Dental Implant System.
| Device ID | K192062 |
| 510k Number | K192062 |
| Device Name: | Nucleoss T6 Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St 10018 Sok. No 7. ITOB Sanayi Bölgesi Tekeli Menderes Izmir, TR 35477 |
| Contact | Ezgi Ozbudak |
| Correspondent | Semih Oktay CardioMed Device Consultants 3168 Braverton St., Suite 200 Edgewater, MD 21037 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2020-08-27 |