FDA 510(k)

3M Filtek Supreme Restitutivo Fluído

Número K: K221695 · 2022-06-13

Requerente3M Company Espe Dental Products

Data da decisão2022-06-13

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: EBF)

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

Fonte oficial

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