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FDA 510(k)

3M Filtek Universal Restorative

K-Number: K183476 · 2019-01-02

Applicant3M Espe Dental Products
Decision Date2019-01-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Filtek Universal Restorative is a medical device manufactured by 3M Espe Dental Products. It received FDA 510(k) clearance on 2019-01-02 under approval number K183476. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by 3M Espe Dental Products. The 510(k) number is K183476.

When was 3M Filtek Universal Restorative approved by the FDA?

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

What company makes 3M Filtek Universal Restorative?

3M Filtek Universal Restorative is manufactured by 3M Espe Dental Products.

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

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

Related Clinical Trials

NCT05361746 Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs COMPLETED NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations RECRUITING

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Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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