FDA 510(k)

DTI-1 SLA IMPLANT SYSTEM

K-번호: K170776 · 2018-04-10

신청자Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi

결정일2018-04-10

제품 코드DZE

자문 위원회DE

결정Substantially Equivalent

기기 요약

DTI-1 SLA IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K170776. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DTI-1 SLA IMPLANT SYSTEM?

DTI-1 SLA IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. The 510(k) number is K170776.

When did DTI-1 SLA IMPLANT SYSTEM receive FDA 510(k) clearance?

DTI-1 SLA IMPLANT SYSTEM received FDA 510(k) clearance on 2018-04-10, under 510(k) number K170776.

Who is the listed applicant for DTI-1 SLA IMPLANT SYSTEM?

The FDA 510(k) record lists Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DTI-1 SLA IMPLANT SYSTEM?

The FDA product code for DTI-1 SLA IMPLANT SYSTEM is DZE.

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DTI-1 SLA IMPLANT SYSTEM

기기 요약

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관련 임상시험

관련 기기 (코드: DZE)

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