Data / Medical devices / Turkey / Dti Implant Systems
Dti Implant Systems: FDA-registered device maker in Kocaeli, Turkey, 1 510(k) clearance
Dti Implant Systems is registered with the FDA (registration 3015218457) in Kocaeli, Turkey. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015218457
- Address
- TUBITAK GEBZE Campus Technology Freezone, Kocaeli, Turkey, 41470
- Owner or operator
- DTI IMPLANT SYSTEMS (10059446)
- Roles
- Manufacturer
- First device listed
- February 4, 2019
- Registered through
- 2026
- Brand names listed
- DTI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2018 | K170776 | DTI-1 SLA IMPLANT SYSTEM | DZE | Substantially Equivalent | Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Drill, Dental, Intraoral
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
Updated April 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.