複合正畸托槽及按鈕
K 號：K251196 · 2025-04-21
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器材摘要
Composite Orthodontic Brackets and Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Ec Certification Service GmbH. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K251196. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Composite Orthodontic Brackets and Buttons?
Composite Orthodontic Brackets and Buttons is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Ec Certification Service GmbH. The 510(k) number is K251196.
When did Composite Orthodontic Brackets and Buttons receive FDA 510(k) clearance?
Composite Orthodontic Brackets and Buttons received FDA 510(k) clearance on 2025-04-21, under 510(k) number K251196.
Who is the listed applicant for Composite Orthodontic Brackets and Buttons?
The FDA 510(k) record lists Ec Certification Service GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Composite Orthodontic Brackets and Buttons?
The FDA product code for Composite Orthodontic Brackets and Buttons is DYW.
相關臨床試驗
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。
相關器械（代碼：DYW）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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