FDA 510(k)

SMARTbase 牙槽體系統

K 號：K223535 · 2023-06-20

申請人Implant Direct Sybron Manufacturing, LLC

決定日期2023-06-20

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

SMARTbase Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K223535. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMARTbase Abutment System?

SMARTbase Abutment System is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K223535.

When did SMARTbase Abutment System receive FDA 510(k) clearance?

SMARTbase Abutment System received FDA 510(k) clearance on 2023-06-20, under 510(k) number K223535.

Who is the listed applicant for SMARTbase Abutment System?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTbase Abutment System?

The FDA product code for SMARTbase Abutment System is NHA.

其他以 Implant Direct Sybron Manufacturing, LLC 為申請人之記錄

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相關器械（代碼：NHA）

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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