FDA 510(k)

Pulpdent Solo Flowable Composite with MCP

K号: K153249 · 2016-04-01

决定日期2016-04-01

产品代码EBF

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决定实质等同

器械摘要

Pulpdent Solo Flowable Composite with MCP is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K153249. 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 Pulpdent Solo Flowable Composite with MCP?

Pulpdent Solo Flowable Composite with MCP is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Pulpdent Corporation. The 510(k) number is K153249.

When did Pulpdent Solo Flowable Composite with MCP receive FDA 510(k) clearance?

Pulpdent Solo Flowable Composite with MCP received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153249.

Who is the listed applicant for Pulpdent Solo Flowable Composite with MCP?

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

What is the FDA product code for Pulpdent Solo Flowable Composite with MCP?

The FDA product code for Pulpdent Solo Flowable Composite with MCP is EBF.

列明Pulpdent Corporation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。

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官方来源

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