FDA 510(k)

维特拉 APS 独特流量

K号: K232994 · 2024-10-18

决定日期2024-10-18

产品代码EBF

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决定实质等同

器械摘要

Vittra APS Unique Flow is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K232994. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vittra APS Unique Flow?

Vittra APS Unique Flow is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Dentscare Ltda. The 510(k) number is K232994.

When did Vittra APS Unique Flow receive FDA 510(k) clearance?

Vittra APS Unique Flow received FDA 510(k) clearance on 2024-10-18, under 510(k) number K232994.

Who is the listed applicant for Vittra APS Unique Flow?

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

What is the FDA product code for Vittra APS Unique Flow?

The FDA product code for Vittra APS Unique Flow is EBF.

列明Dentscare Ltda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。

K231859PrimmaArt K210231Vittra APS 独特 K201707Opallis，Opallis Flow K192682Orthocem, Ortho Bite K191389Allcem Veneer APS K191306Llis, Vittra APS

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官方来源

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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。