FDA 510(k)

磷酸鹽蝕刻膠

K 號：K221450 · 2022-09-12

申請人Rizhao Huge Biomaterials Company, Ltd.

決定日期2022-09-12

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

Phosphoric Acid Etching Gel is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2022-09-12 under 510(k) number K221450. 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 Phosphoric Acid Etching Gel?

Phosphoric Acid Etching Gel is a medical device that received FDA 510(k) clearance on 2022-09-12. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K221450.

When did Phosphoric Acid Etching Gel receive FDA 510(k) clearance?

Phosphoric Acid Etching Gel received FDA 510(k) clearance on 2022-09-12, under 510(k) number K221450.

Who is the listed applicant for Phosphoric Acid Etching Gel?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phosphoric Acid Etching Gel?

The FDA product code for Phosphoric Acid Etching Gel is KLE.

其他以 Rizhao Huge Biomaterials Company, 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。

K252785TopCEM Vigor SA 自粘性樹脂水泥 K251271TempFIT 暫時冠橋膠 K242572TopCEM-Try 薄層試戴膠 K242530HF-鹵化氫酸蝕刻膠 K242749TopCEM陶瓷底漆陶瓷耦合劑 K241204TopCEM-貼面光固化貼面水泥

查看所有 13 項裝置 →

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

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。