FDA 510(k)

3M Filtek Universal Restorative

K号: K183476 · 2019-01-02

决定日期2019-01-02

产品代码EBF

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决定实质等同

器械摘要

3M Filtek Universal Restorative is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K183476. 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 Universal Restorative?

3M Filtek Universal Restorative is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is 3M Espe Dental Products. The 510(k) number is K183476.

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

3M Filtek Universal Restorative received FDA 510(k) clearance on 2019-01-02, under 510(k) number K183476.

Who is the listed applicant for 3M Filtek Universal Restorative?

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

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

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

列明3M Espe Dental Products为申报人的其他记录

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