FDA 510(k)

LW植入系統 – 牙根擴張器

K 號：K233167 · 2024-03-25

決定日期2024-03-25

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

LW Implant System – 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 2024-03-25 under 510(k) number K233167. 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 Implant System – Abutment?

LW Implant System – Abutment is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K233167.

When did LW Implant System – Abutment receive FDA 510(k) clearance?

LW Implant System – Abutment received FDA 510(k) clearance on 2024-03-25, under 510(k) number K233167.

Who is the listed applicant for LW Implant System – 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 Implant System – Abutment?

The FDA product code for LW Implant System – 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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