假牙基托树脂（PN-假牙（红色，白色））
K号: K241673 · 2024-10-15
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决定日期2024-10-15
产品代码EBF
咨询委员会DE
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决定实质等同
器械摘要
Denture Base Resin (PN-Denture (Red, White)) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Piocreat 3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K241673. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Denture Base Resin (PN-Denture (Red, White))?
Denture Base Resin (PN-Denture (Red, White)) is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Shenzhen Piocreat 3D Technology Co., Ltd.. The 510(k) number is K241673.
When did Denture Base Resin (PN-Denture (Red, White)) receive FDA 510(k) clearance?
Denture Base Resin (PN-Denture (Red, White)) received FDA 510(k) clearance on 2024-10-15, under 510(k) number K241673.
Who is the listed applicant for Denture Base Resin (PN-Denture (Red, White))?
The FDA 510(k) record lists Shenzhen Piocreat 3D Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Denture Base Resin (PN-Denture (Red, White))?
The FDA product code for Denture Base Resin (PN-Denture (Red, White)) is EBF.
相关临床试验
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相关器械（代码：EBF）
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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