TEMP MASTER, PMMA基牙科树脂
K号: K243951 · 2025-02-21
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决定日期2025-02-21
产品代码EBG
咨询委员会DE
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决定实质等同
器械摘要
TEMP MASTER, PMMA-based dental resin is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243951. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TEMP MASTER, PMMA-based dental resin?
TEMP MASTER, PMMA-based dental resin is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Taiwan Dental Materials Co., Ltd.. The 510(k) number is K243951.
When did TEMP MASTER, PMMA-based dental resin receive FDA 510(k) clearance?
TEMP MASTER, PMMA-based dental resin received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243951.
Who is the listed applicant for TEMP MASTER, PMMA-based dental resin?
The FDA 510(k) record lists Taiwan Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TEMP MASTER, PMMA-based dental resin?
The FDA product code for TEMP MASTER, PMMA-based dental resin is EBG.
相关临床试验
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。
相关器械（代码：EBG）
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。
K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基础”和“FLNT 临时”Liaoning Upcera Co., Ltd.K251271TempFIT 临时牙冠和牙桥树脂Rizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK242559数字温度计Sprintray, Inc.
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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