Clear Aligner (SCF-3348)
K号: K251454 · 2026-01-07
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决定日期2026-01-07
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
Clear Aligner (SCF-3348) is the device name listed in this FDA 510(k) record. The listed applicant is Beame Medical Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K251454. 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 Clear Aligner (SCF-3348)?
Clear Aligner (SCF-3348) is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Beame Medical Technology (Shenzhen) Limited. The 510(k) number is K251454.
When did Clear Aligner (SCF-3348) receive FDA 510(k) clearance?
Clear Aligner (SCF-3348) received FDA 510(k) clearance on 2026-01-07, under 510(k) number K251454.
Who is the listed applicant for Clear Aligner (SCF-3348)?
The FDA 510(k) record lists Beame Medical Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clear Aligner (SCF-3348)?
The FDA product code for Clear Aligner (SCF-3348) is NXC.
相关临床试验
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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。
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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