治療筆牙科固化燈
K 號：K221152 · 2022-11-23
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器材摘要
CuringPen Dental Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K221152. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CuringPen Dental Curing Light?
CuringPen Dental Curing Light is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K221152.
When did CuringPen Dental Curing Light receive FDA 510(k) clearance?
CuringPen Dental Curing Light received FDA 510(k) clearance on 2022-11-23, under 510(k) number K221152.
Who is the listed applicant for CuringPen Dental Curing Light?
FDA 510(k) 記錄將常州市思法瑞醫療科技有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for CuringPen Dental Curing Light?
The FDA product code for CuringPen Dental Curing Light is EBZ.
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。
其他以 Changzhou Sifary Medical Technology Co., Ltd. 為申請人之記錄
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：EBZ）
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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