FDA 510(k)

KATANA 鑫鎂ONE 用於植入

K 號：K233285 · 2024-05-24

決定日期2024-05-24

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

KATANA Zirconia ONE For IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K233285. 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 KATANA Zirconia ONE For IMPLANT?

KATANA Zirconia ONE For IMPLANT is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K233285.

When did KATANA Zirconia ONE For IMPLANT receive FDA 510(k) clearance?

KATANA Zirconia ONE For IMPLANT received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233285.

Who is the listed applicant for KATANA Zirconia ONE For IMPLANT?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KATANA Zirconia ONE For IMPLANT?

The FDA product code for KATANA Zirconia ONE For IMPLANT is NHA.

其他以 Kuraray Noritake Dental, Inc. 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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