FDA 510(k)

SFIT 牙槽橋

K 號：K242287 · 2025-09-16

決定日期2025-09-16

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

SFIT Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2025-09-16 under 510(k) number K242287. 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 SFIT Abutment?

SFIT Abutment is a medical device that received FDA 510(k) clearance on 2025-09-16. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K242287.

When did SFIT Abutment receive FDA 510(k) clearance?

SFIT Abutment received FDA 510(k) clearance on 2025-09-16, under 510(k) number K242287.

Who is the listed applicant for SFIT Abutment?

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

What is the FDA product code for SFIT Abutment?

The FDA product code for SFIT Abutment is NHA.

其他以 Cowellmedi 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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