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FDA 510(k)

TP 正畸光固化粘合剂系统，TP 正畸预应用粘合剂，TP 正畸蚀刻208520

K号: K214054 · 2022-10-14

申请人Tp Orthodontics, Inc.
决定日期2022-10-14
产品代码DYH
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决定实质等同

器械摘要

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is the device name listed in this FDA 510(k) record. The listed applicant is Tp Orthodontics, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K214054. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Tp Orthodontics, Inc.. The 510(k) number is K214054.

When did TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 receive FDA 510(k) clearance?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 received FDA 510(k) clearance on 2022-10-14, under 510(k) number K214054.

Who is the listed applicant for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

The FDA 510(k) record lists Tp Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

The FDA product code for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is DYH.

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

列明Tp Orthodontics, 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。

K193385TP 正畸透明矫治器系统

相关器械（代码：DYH）

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。

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco® EtchFree Bonding System, Ormco® EtchFree Bonding Primer, Ormco® EtchFree AdhesiveOrmco CorporationK242537BracePaste氟化物密封剂American Orthodontics Corp.K2340433M® Transbond® Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

官方来源

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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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