FDA 510(k)

陶瓷蝕刻劑 (HF-5 和 HF-9)

K 號：K240153 · 2024-10-02

決定日期2024-10-02

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

Ceramic Etchant (HF-5 and HF-9) is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K240153. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceramic Etchant (HF-5 and HF-9)?

Ceramic Etchant (HF-5 and HF-9) is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K240153.

When did Ceramic Etchant (HF-5 and HF-9) receive FDA 510(k) clearance?

Ceramic Etchant (HF-5 and HF-9) received FDA 510(k) clearance on 2024-10-02, under 510(k) number K240153.

Who is the listed applicant for Ceramic Etchant (HF-5 and HF-9)?

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

What is the FDA product code for Ceramic Etchant (HF-5 and HF-9)?

The FDA product code for Ceramic Etchant (HF-5 and HF-9) is KLE.

其他以 Liaoning Upcera 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。

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相關器械（代碼：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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