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FDA 510(k)

edelweiss CAD/CAM T-BLOCK；edelweiss CAD/CAM C-BLOCK；edelweiss CAD/CAM i-BLOCK；Ceramir CAD/CAM T-BLOCK；Ceramir CAD/CAM C-BLOCK；Ceramir CAD/CAM i-BLOCK

K号: K241131 · 2024-10-18

申请人Edelweiss Dentistry Products GmbH
决定日期2024-10-18
产品代码EBF
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决定实质等同

器械摘要

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Edelweiss Dentistry Products GmbH. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K241131. 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 edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK?

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Edelweiss Dentistry Products GmbH. The 510(k) number is K241131.

When did edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK receive FDA 510(k) clearance?

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK received FDA 510(k) clearance on 2024-10-18, under 510(k) number K241131.

Who is the listed applicant for edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK?

The FDA 510(k) record lists Edelweiss Dentistry Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK?

The FDA product code for edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK is EBF.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.K261246SRGC-06GC America, Inc.

官方来源

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