FDA 510(k)

美學牙根 Nobel Biocare N1

K 號：K220339 · 2022-09-16

決定日期2022-09-16

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Esthetic Abutments Nobel Biocare N1 is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K220339. 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 Esthetic Abutments Nobel Biocare N1?

Esthetic Abutments Nobel Biocare N1 is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K220339.

When did Esthetic Abutments Nobel Biocare N1 receive FDA 510(k) clearance?

Esthetic Abutments Nobel Biocare N1 received FDA 510(k) clearance on 2022-09-16, under 510(k) number K220339.

Who is the listed applicant for Esthetic Abutments Nobel Biocare N1?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esthetic Abutments Nobel Biocare N1?

The FDA product code for Esthetic Abutments Nobel Biocare N1 is NHA.

其他以 Nobel Biocare Services AG 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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