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DTİ İmplant Sistemleri

Also known as: DTI Implant Systems, DTİ İmplant Sistemleri San. Tic. A.Ş.

A Turkish dental implant manufacturer in İstanbul that developed its implant systems with support from the national research council TÜBİTAK.

Key facts

CountryTurkeyVerified spec[1][2]
HeadquartersÇekmeköy, İstanbul, TurkeyVerified spec[1]
OwnershipJoint-stock company (A.Ş.)Verified spec[2]
FoundedManufacturer documentation not located(The about page describes the company history but does not state a founding year.)

Overview

DTİ İmplant Sistemleri is an İstanbul manufacturer that presents its implants as domestically developed with support from TÜBİTAK, the Turkish national scientific and technological research council, and the Council of Europe Development Bank. That development backing is unusual among Turkish implant firms and is the most distinctive fact about the company. Its product-level documentation in English is limited, so dimensions and other technical specifications are not recorded here.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance1 record

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K170776DTI-1 SLA IMPLANT SYSTEMDti Implant Sistemleri Sanayi Ticaret Anonim Sirketi2018-04-10

Clearance records for DTİ İmplant Sistemleri were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to DTİ İmplant Sistemleri.

Sources

Numbers match the citations beside each claim above.

Primary sources

Additional references

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