FDA 510(k)

APAPRO 家用脱敏剂（再矿化抗敏感牙膏）

K号: K260830 · 2026-03-18

决定日期2026-03-18

产品代码LBH

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is the device name listed in this FDA 510(k) record. The listed applicant is Sangi Co., Ltd.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K260830. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Sangi Co., Ltd.. The 510(k) number is K260830.

When did APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) receive FDA 510(k) clearance?

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) received FDA 510(k) clearance on 2026-03-18, under 510(k) number K260830.

Who is the listed applicant for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

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

What is the FDA product code for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

The FDA product code for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is LBH.

列明Sangi Co., 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。

K220419Apapro脱敏剂

官方来源

在 FDA 数据库中查看 →

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。