Data / Medical devices / Turkey / Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi: FDA-registered device maker in Izmir, Turkey, 1 510(k) clearance
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi is registered with the FDA (registration 3014112268) in Izmir, Turkey. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014112268
- Address
- ITOB Sanayi Bolgesi 10018 sok no 7 Tekeli Menderes, Izmir, Turkey, 35477
- Owner or operator
- Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi ve Ticaret Anon (10056145)
- Roles
- Manufacturer
- First device listed
- December 15, 2021
- Registered through
- 2026
- Brand names listed
- Nucleoss
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | 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 |
|---|---|---|---|---|---|---|
| August 27, 2020 | K192062 | Nucleoss T6 Dental Implant System | DZE | Substantially Equivalent | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2020. 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.