FDA 510(k)

LW 預磨牙根台

K 號：K242703 · 2024-12-05

決定日期2024-12-05

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

LW Pre-milled Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K242703. 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 LW Pre-milled Abutment?

LW Pre-milled Abutment is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K242703.

When did LW Pre-milled Abutment receive FDA 510(k) clearance?

LW Pre-milled Abutment received FDA 510(k) clearance on 2024-12-05, under 510(k) number K242703.

Who is the listed applicant for LW Pre-milled Abutment?

The FDA 510(k) record lists Ossvis Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LW Pre-milled Abutment?

The FDA product code for LW Pre-milled Abutment is NHA.

其他以 Ossvis Co., Ltd. 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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