The following data is part of a premarket notification filed by Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi with the FDA for Dti-1 Sla Implant System.
| Device ID | K170776 |
| 510k Number | K170776 |
| Device Name: | DTI-1 SLA IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DTI Implant Sistemleri Sanayi Ticaret Anonim Sirketi D1-2 No 5 Merkez Mahallesi Cekmekoy, TR 34782 |
| Contact | Fatih Ormeci |
| Correspondent | Fatih Ormeci MEDCER USA 16 Midland Ave Hicksville, NY 11801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-14 |
| Decision Date | 2018-04-10 |