增材制造氧化锆定制修复体
K号: K240586 · 2024-10-03
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决定日期2024-10-03
产品代码ELL
咨询委员会DE
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决定实质等同
器械摘要
Additive Manufacturing Zirconia Customized Restoration is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Thales Medtech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K240586. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Additive Manufacturing Zirconia Customized Restoration?
Additive Manufacturing Zirconia Customized Restoration is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Hangzhou Thales Medtech Co., Ltd.. The 510(k) number is K240586.
When did Additive Manufacturing Zirconia Customized Restoration receive FDA 510(k) clearance?
Additive Manufacturing Zirconia Customized Restoration received FDA 510(k) clearance on 2024-10-03, under 510(k) number K240586.
Who is the listed applicant for Additive Manufacturing Zirconia Customized Restoration?
The FDA 510(k) record lists Hangzhou Thales Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Additive Manufacturing Zirconia Customized Restoration?
The FDA product code for Additive Manufacturing Zirconia Customized Restoration is ELL.
相关临床试验
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相关器械（代码：ELL）
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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