FDA 510(k)

SIMDA 牙槽體

K 號：K252320 · 2025-12-18

決定日期2025-12-18

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

SIMDA Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Simda Co., Ltd.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252320. 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 SIMDA Abutments?

SIMDA Abutments is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Simda Co., Ltd.. The 510(k) number is K252320.

When did SIMDA Abutments receive FDA 510(k) clearance?

SIMDA Abutments received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252320.

Who is the listed applicant for SIMDA Abutments?

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

What is the FDA product code for SIMDA Abutments?

The FDA product code for SIMDA Abutments is NHA.

其他以 Simda Co., Ltd. 為申請人之記錄

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K232271SIMDA 嵌入體 K223663SIMDA 牙根支台

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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