复合正畸托槽和按钮
K号: K251196 · 2025-04-21
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决定日期2025-04-21
产品代码DYW
咨询委员会DE
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决定实质等同
器械摘要
Composite Orthodontic Brackets and Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Ec Certification Service GmbH. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K251196. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Composite Orthodontic Brackets and Buttons?
Composite Orthodontic Brackets and Buttons is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Ec Certification Service GmbH. The 510(k) number is K251196.
When did Composite Orthodontic Brackets and Buttons receive FDA 510(k) clearance?
Composite Orthodontic Brackets and Buttons received FDA 510(k) clearance on 2025-04-21, under 510(k) number K251196.
Who is the listed applicant for Composite Orthodontic Brackets and Buttons?
The FDA 510(k) record lists Ec Certification Service GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Composite Orthodontic Brackets and Buttons?
The FDA product code for Composite Orthodontic Brackets and Buttons is DYW.
相关临床试验
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相关器械（代码：DYW）
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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