SRGC-06
K号: K261246 · 2026-06-18
广告
决定日期2026-06-18
产品代码EBF
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
SRGC-06 is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261246. 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 SRGC-06?
SRGC-06 is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is GC America, Inc.. The 510(k) number is K261246.
When did SRGC-06 receive FDA 510(k) clearance?
SRGC-06 received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261246.
Who is the listed applicant for SRGC-06?
FDA 510(k)记录中列出GC America, Inc.为申请人。这本身并不足以确立该设备的制造商。
What is the FDA product code for SRGC-06?
The FDA product code for SRGC-06 is EBF.
列明GC America, Inc.为申报人的其他记录
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：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。
K262982Core·it 双核Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流动修复材料（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228超越大体积填充流动复合树脂Ultradent Products, Inc.K261093DIAFILDiaDent Group International
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。
广告