FDA 510(k)

Visalys CemCore，Visalys Cem Core 尝试粘贴

K号: K191527 · 2019-11-08

决定日期2019-11-08

产品代码EMA

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Visalys CemCore, Visalys Cem Core Try In Paste 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 2019-11-08 under 510(k) number K191527. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Visalys CemCore, Visalys Cem Core Try In Paste?

Visalys CemCore, Visalys Cem Core Try In Paste is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K191527.

When did Visalys CemCore, Visalys Cem Core Try In Paste receive FDA 510(k) clearance?

Visalys CemCore, Visalys Cem Core Try In Paste received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191527.

Who is the listed applicant for Visalys CemCore, Visalys Cem Core Try In Paste?

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 Visalys CemCore, Visalys Cem Core Try In Paste?

The FDA product code for Visalys CemCore, Visalys Cem Core Try In Paste is EMA.

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 Free K250267Visalys® 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）K230333Profisil 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）K191523维萨利斯修复底漆 K191524维萨利斯牙釉质预处理剂

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。