UltraThineer 锆英砂浆（5Y-B）
K号: K240419 · 2024-04-12
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决定日期2024-04-12
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
UltraThineer Zirconia Slurry (5Y-B) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Micro Fabrication. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240419. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UltraThineer Zirconia Slurry (5Y-B)?
UltraThineer Zirconia Slurry (5Y-B) is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Boston Micro Fabrication. The 510(k) number is K240419.
When did UltraThineer Zirconia Slurry (5Y-B) receive FDA 510(k) clearance?
UltraThineer Zirconia Slurry (5Y-B) received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240419.
Who is the listed applicant for UltraThineer Zirconia Slurry (5Y-B)?
The FDA 510(k) record lists Boston Micro Fabrication as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltraThineer Zirconia Slurry (5Y-B)?
The FDA product code for UltraThineer Zirconia Slurry (5Y-B) is EIH.
相关临床试验
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相关器械（代码：EIH）
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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