整體牙科設備
K 號：K243130 · 2025-06-27
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器材摘要
Integral Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Yadeng Medical Apparatus Co., Ltd.,. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243130. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Integral Dental Unit?
Integral Dental Unit is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Guangdong Yadeng Medical Apparatus Co., Ltd.,. The 510(k) number is K243130.
When did Integral Dental Unit receive FDA 510(k) clearance?
Integral Dental Unit received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243130.
Who is the listed applicant for Integral Dental Unit?
The FDA 510(k) record lists Guangdong Yadeng Medical Apparatus Co., Ltd., as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Integral Dental Unit?
The FDA product code for Integral Dental Unit is EIA.
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：EIA）
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
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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