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FDA 510(k)

Profisil 氟化物漆组合包装（14801），Profisil 氟化物漆常规包装薄荷（14802），Profisil 氟化物漆常规包装浆果（14804），Profisil 氟化物漆常规包装无味（14806），Profisil 氟化物漆样品包装（14800）

K号: K230333 · 2023-07-24

申请人Kettenbach GmbH & Co. KG
决定日期2023-07-24
产品代码LBH
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决定实质等同

器械摘要

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2023-07-24 under 510(k) number K230333. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is a medical device that received FDA 510(k) clearance on 2023-07-24. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K230333.

When did Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) receive FDA 510(k) clearance?

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) received FDA 510(k) clearance on 2023-07-24, under 510(k) number K230333.

Who is the listed applicant for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

FDA 510(k)记录中列出Kettenbach GmbH & Co. KG为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

The FDA product code for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is LBH.

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Kettenbach GmbH & Co. KG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。

K262243Profisil FreeK250267Visalys® 大量填充 1 x 4 g 注射器（15060）；Visalys® 大量填充 15 x 0.25 g 填充胶囊（15062）；Visalys® 大量流动 1 x 2 g 注射器（15064）；Visalys® 大量流动 15 x 0.25 g 填充胶囊（15066）；Visalys® 大量流动入门套装（15067）；Visalys® 大量填充入门套装（15068）K191527Visalys CemCore，Visalys Cem Core 尝试粘贴K191523维萨利斯修复底漆K191524维萨利斯牙釉质预处理剂

相关器械（代码：LBH）

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。

K262243Profisil FreeKettenbach GmbH & Co. KGK253052氟化物漆（类型A，类型C）Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid 漱口水 + BioMinVoco GmbHK261404超易用Ultradent Products, Inc.K260830APAPRO 家用脱敏剂（再矿化抗敏感牙膏）Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.

官方来源

在 FDA 数据库中查看 →

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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