FDA 510(k)

Nanova 2 步蚀刻和冲洗牙科粘合剂，Nanova 蚀刻凝胶

K号: K172977 · 2018-01-16

决定日期2018-01-16

产品代码KLE

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决定实质等同

器械摘要

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172977. 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 Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K172977.

When did Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel receive FDA 510(k) clearance?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172977.

Who is the listed applicant for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

The FDA 510(k) record lists Nanova Biomaterials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

The FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is KLE.

列明Nanova Biomaterials, Inc.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。

K171330Nanova 密封剂 K163672Nanova 推入缝合锚，Nanova 推入缝合锚 K161174Nanova 干扰螺丝 K151943Vas-Q-Clip

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。