HEXIM 移植物；Samwon 一般基台
K号: K243731 · 2025-07-09
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申请人P&A USA
决定日期2025-07-09
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
HEXIM Implant; Samwon General Abutments is the device name listed in this FDA 510(k) record. The listed applicant is P&A USA. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K243731. 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 HEXIM Implant; Samwon General Abutments?
HEXIM Implant; Samwon General Abutments is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is P&A USA. The 510(k) number is K243731.
When did HEXIM Implant; Samwon General Abutments receive FDA 510(k) clearance?
HEXIM Implant; Samwon General Abutments received FDA 510(k) clearance on 2025-07-09, under 510(k) number K243731.
Who is the listed applicant for HEXIM Implant; Samwon General Abutments?
The FDA 510(k) record lists P&A USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HEXIM Implant; Samwon General Abutments?
The FDA product code for HEXIM Implant; Samwon General Abutments 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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