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FDA 510(k)

tün® 超声波探头产品系列

K号: K182145 · 2019-06-07

申请人Engineered Endodontics
决定日期2019-06-07
产品代码ELC
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决定实质等同

器械摘要

tün® ultrasonic tips product family is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Endodontics. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K182145. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the tün® ultrasonic tips product family?

tün® ultrasonic tips product family is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Engineered Endodontics. The 510(k) number is K182145.

When did tün® ultrasonic tips product family receive FDA 510(k) clearance?

tün® ultrasonic tips product family received FDA 510(k) clearance on 2019-06-07, under 510(k) number K182145.

Who is the listed applicant for tün® ultrasonic tips product family?

The FDA 510(k) record lists Engineered Endodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for tün® ultrasonic tips product family?

The FDA product code for tün® ultrasonic tips product family is ELC.

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：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX 放大镜系统（VA170LUXS10）；VARIOS 170 LUX 放大镜系统（VA170LUXS11）；VARIOS 170 放大镜系统（VA170S11）Nakanishi, Inc.K242317集成式内窥镜系统（Meet Endo-II）Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707超声波洁牙器（WD-JY-B002，WD-JY-W001，WD-JY-R003，WD-JY-G004，WD-JY-B003，WD-JY-C006，WD-JY-M0014，WD-JY-N0015，WD-JY-N0016，WD-JY-N0017，WD-JY-E007，WD-JY-F008，WD-JY-A005，WD-JY-H009，WD-JY-I0011，WD-JY-K0012，WD-JY-K0013，WD-JY-K0014，WD-JY-L0013，WD-JY-L0014，WD-JY-L0015，WD-JY-L0016，WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.

官方来源

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