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Şanlılar Tıbbi Cihazlar

Also known as: Şanlılar Tıbbi Cihazlar Medikal Kimya San. Tic. Ltd. Şti., Sanlilar

The İzmir-based Turkish company that manufactures the NucleOSS dental implant systems.

Key facts

CountryTurkeyVerified spec[1]
HeadquartersİTOB Organised Industrial Zone, Menderes, İzmir, TurkeyVerified spec[2]
Founded2001Verified spec[1]
OwnershipPrivate limited company (Ltd. Şti.)Verified spec[4]
Geographic availabilityEuropean distribution handled through Nucleoss Europe GmbH, Heppenheim, GermanyManufacturer-reported[2]
manufacturingCountryTurkeyVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Şanlılar Tıbbi Cihazlar is the İzmir company that makes the NucleOSS implant range; the brand is more widely recognised than the company name, so a patient record naming only "NucleOSS" does identify the maker. It is one of the older Turkish implant manufacturers, dating its implant work to the early 2000s, and it maintains a German subsidiary as its European representative. That European presence matters for parts supply in the EU, though it says nothing on its own about clinical results, which are a separate question answered by studies.

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) clearance2 records

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

NumberDeviceHolderDate
K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST2020-08-27
K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti2017-08-04

Other1 record

Registered device establishment in Turkey. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

NumberDeviceHolderDate
3014112268—SANLILAR TIBBI CIHAZLAR MEDIKAL KIMYA SANAYI TICARET LIMITED SIRKETI—

Clearance records for Şanlılar Tıbbi Cihazlar 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 Şanlılar Tıbbi Cihazlar.

Sources

Numbers match the citations beside each claim above.

Primary sources

Additional references

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