CeraRoot TL Implant System (TL)
K号: K242072 · 2025-05-14
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申请人Ceraroot SL
决定日期2025-05-14
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
CeraRoot TL Implant System (TL) is the device name listed in this FDA 510(k) record. The listed applicant is Ceraroot SL. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K242072. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CeraRoot TL Implant System (TL)?
CeraRoot TL Implant System (TL) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Ceraroot SL. The 510(k) number is K242072.
When did CeraRoot TL Implant System (TL) receive FDA 510(k) clearance?
CeraRoot TL Implant System (TL) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242072.
Who is the listed applicant for CeraRoot TL Implant System (TL)?
The FDA 510(k) record lists Ceraroot SL as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CeraRoot TL Implant System (TL)?
The FDA product code for CeraRoot TL Implant System (TL) is DZE.
相关临床试验
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相关器械（代码：DZE）
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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