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FDA 510(k)

3M Filtek Supreme Flowable Restorative

K-Number: K221695 · 2022-06-13

Applicant3M Company Espe Dental Products
Decision Date2022-06-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Filtek Supreme Flowable Restorative is a medical device manufactured by 3M Company Espe Dental Products. It received FDA 510(k) clearance on 2022-06-13 under approval number K221695. 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 Supreme Flowable Restorative?

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

When was 3M Filtek Supreme Flowable Restorative approved by the FDA?

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

What company makes 3M Filtek Supreme Flowable Restorative?

3M Filtek Supreme Flowable Restorative is manufactured by 3M Company Espe Dental Products.

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

The FDA product code for 3M Filtek Supreme Flowable 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

Related Devices (Code: EBF)

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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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