FDA 510(k)

磷酸酸蚀凝胶

K号: K221450 · 2022-09-12

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2022-09-12

产品代码KLE

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决定实质等同

器械摘要

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.

常见问题

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.

列明Rizhao Huge Biomaterials Company, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252785TopCEM Vigor SA 自粘树脂粘合剂 K251271TempFIT 临时牙冠和牙桥树脂 K242572TopCEM-Try 在体试戴凝胶 K242530HF-Etchant 氢氟酸蚀刻凝胶 K242749TopCEM 陶瓷底漆陶瓷耦合剂 K241204TopCEM-贴面光固化贴面水泥

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官方来源

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