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FDA 510(k)

Sildent 快速轻体，Sildent 快速重体，Sildent 咬合

K号: K181604 · 2018-11-28

申请人Hrs Co., Ltd.
决定日期2018-11-28
产品代码ELW
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决定实质等同

器械摘要

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is the device name listed in this FDA 510(k) record. The listed applicant is Hrs Co., Ltd.. It received FDA 510(k) clearance on 2018-11-28 under 510(k) number K181604. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is Hrs Co., Ltd.. The 510(k) number is K181604.

When did Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite receive FDA 510(k) clearance?

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite received FDA 510(k) clearance on 2018-11-28, under 510(k) number K181604.

Who is the listed applicant for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

The FDA 510(k) record lists Hrs Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

The FDA product code for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is ELW.

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：ELW）

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。

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142迪亚-X 硅重体DiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium 快速设置 - 454g (1lb) (052037)；Hydro Print Premium 标准设置 - 454g (1lb) (052327)；Chroma Print Premium 快速设置 - 454g (1lb) (052457)；Chroma Print Premium 标准设置 - 454g (1lb) (051460)；Perfil Pro - 454g (1lb) (056213)；Perfil Pro+ - 454g (1lb) (056121)；Perfil Pro Chroma - 454g (1lb) (056122)；Hydro Print Premium 快速设置 - 多包装 (056205)；Hydro Print Premium 标准设置 - 多包装 (056208)；Hydro Print Premium 快速设置 - 9,07Kg (20lb) (056204)；Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

官方来源

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