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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 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.

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. 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.

Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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