Smylio 矫正器
K号: K260788 · 2026-05-08
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申请人Smylio, Inc.
决定日期2026-05-08
产品代码NXC
咨询委员会DE
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决定实质等同
器械摘要
Smylio Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Smylio, Inc.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K260788. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Smylio Aligners?
Smylio Aligners is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Smylio, Inc.. The 510(k) number is K260788.
When did Smylio Aligners receive FDA 510(k) clearance?
Smylio Aligners received FDA 510(k) clearance on 2026-05-08, under 510(k) number K260788.
Who is the listed applicant for Smylio Aligners?
The FDA 510(k) record lists Smylio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Smylio Aligners?
The FDA product code for Smylio Aligners is NXC.
相关临床试验
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列明Smylio, 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。
相关器械（代码：NXC）
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。
K260527FACE4D矫正器Avinent Implant System S.L.U.K260722SureSmile 矫正器 (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile系统Dror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint直接矫正器Dreve Dentamid GmbHK252931Invisalign® 上颌扩张器系统Align Technology, Inc.
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。
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