FDA 510(k)

核心斯T6牙植體系統

K 號：K192062 · 2020-08-27

申請人Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST

決定日期2020-08-27

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Nucleoss T6 Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K192062. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nucleoss T6 Dental Implant System?

Nucleoss T6 Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST. The 510(k) number is K192062.

When did Nucleoss T6 Dental Implant System receive FDA 510(k) clearance?

Nucleoss T6 Dental Implant System received FDA 510(k) clearance on 2020-08-27, under 510(k) number K192062.

Who is the listed applicant for Nucleoss T6 Dental Implant System?

The FDA 510(k) record lists Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nucleoss T6 Dental Implant System?

The FDA product code for Nucleoss T6 Dental Implant System is DZE.

相關器械（代碼：DZE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DZE）

官方來源