Smile Dx®
K号: K242437 · 2025-05-14
广告
器械摘要
Smile Dx® is the device name listed in this FDA 510(k) record. The listed applicant is Cube Click, Inc.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K242437. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Smile Dx®?
Smile Dx® is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Cube Click, Inc.. The 510(k) number is K242437.
When did Smile Dx® receive FDA 510(k) clearance?
Smile Dx® received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242437.
Who is the listed applicant for Smile Dx®?
The FDA 510(k) record lists Cube Click, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Smile Dx®?
The FDA product code for Smile Dx® is MYN.
相关临床试验
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。
相关器械（代码：MYN）
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。
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。
广告