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FDA 510(k)

牙齒植體系統

K 號:K250806 · 2026-06-18

決定日期2026-06-18
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Devices , Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K250806. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental Implant System?

Dental Implant System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is A.B. Dental Devices , Ltd.. The 510(k) number is K250806.

When did Dental Implant System receive FDA 510(k) clearance?

Dental Implant System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K250806.

Who is the listed applicant for Dental Implant System?

The FDA 510(k) record lists A.B. Dental Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implant System?

The FDA product code for Dental Implant System is DZE.

相關臨床試驗

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相關器械(代碼:DZE)

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。

官方來源

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