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FDA 510(k)

3M Filtek Supreme Flowable Restorative

K号: K221695 · 2022-06-13

决定日期2022-06-13
产品代码EBF
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决定实质等同

器械摘要

3M Filtek Supreme Flowable Restorative is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company Espe Dental Products. It received FDA 510(k) clearance on 2022-06-13 under 510(k) number K221695. 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 3M Filtek Supreme Flowable Restorative?

3M Filtek Supreme Flowable Restorative is a medical device that received FDA 510(k) clearance on 2022-06-13. The listed applicant is 3M Company Espe Dental Products. The 510(k) number is K221695.

When did 3M Filtek Supreme Flowable Restorative receive FDA 510(k) clearance?

3M Filtek Supreme Flowable Restorative received FDA 510(k) clearance on 2022-06-13, under 510(k) number K221695.

Who is the listed applicant for 3M Filtek Supreme Flowable Restorative?

The FDA 510(k) record lists 3M Company Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Filtek Supreme Flowable Restorative?

The FDA product code for 3M Filtek Supreme Flowable Restorative is EBF.

相关临床试验

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相关器械(代码:EBF)

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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