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FDA 510(k)

EDS 结石软化剂 TURBO CR

K号: K223340 · 2023-12-11

申请人Essential Dental Systems, Inc.
决定日期2023-12-11
产品代码ELC
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决定实质等同

器械摘要

EDS Calculus Softener TURBO CR is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K223340. 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 EDS Calculus Softener TURBO CR?

EDS Calculus Softener TURBO CR is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K223340.

When did EDS Calculus Softener TURBO CR receive FDA 510(k) clearance?

EDS Calculus Softener TURBO CR received FDA 510(k) clearance on 2023-12-11, under 510(k) number K223340.

Who is the listed applicant for EDS Calculus Softener TURBO CR?

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

What is the FDA product code for EDS Calculus Softener TURBO CR?

The FDA product code for EDS Calculus Softener TURBO CR 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

列明Essential Dental Systems, 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。

K152691EDS 通用水泥

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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