Helioseal F Plus
K号: K190339 · 2019-07-29
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决定日期2019-07-29
产品代码EBC
咨询委员会DE
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决定实质等同
器械摘要
Helioseal F Plus is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K190339. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Helioseal F Plus?
Helioseal F Plus is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K190339.
When did Helioseal F Plus receive FDA 510(k) clearance?
Helioseal F Plus received FDA 510(k) clearance on 2019-07-29, under 510(k) number K190339.
Who is the listed applicant for Helioseal F Plus?
The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helioseal F Plus?
The FDA product code for Helioseal F Plus is EBC.
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。
列明Ivoclar Vivadent, AG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。
相关器械（代码：EBC）
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。
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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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