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FDA 510(k)

Crown 牙齿氧化锆空白块 & Crown 牙齿氧化锆预着色空白块

K号: K180252 · 2018-04-24

申请人Crown Porcelain Dental Technology Co., Ltd.
决定日期2018-04-24
产品代码EIH
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决定实质等同

器械摘要

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Crown Porcelain Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K180252. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Crown Porcelain Dental Technology Co., Ltd.. The 510(k) number is K180252.

When did Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2018-04-24, under 510(k) number K180252.

Who is the listed applicant for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

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

What is the FDA product code for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

The FDA product code for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is EIH.

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：EIH）

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。

K262074任何-ZircosMediclus Co., Ltd.K262239Obsidian® 压力压过氧化锆Prismatik Dentalcraft, Inc.K261046牙科氧化锆空白块及着色液体Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy 陶瓷颜料和釉料Zima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM，Rosetta SPHass Corp.

官方来源

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