FDA 510(k)

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)

Número K: K210473 · 2021-11-02

RequerenteImicryl Dis Malzemeleri Sanayi VE Ticaret AS

Data da decisão2021-11-02

Código do produtoEMA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2021-11-02 under 510(k) number K210473. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K210473.

When did Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) receive FDA 510(k) clearance?

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) received FDA 510(k) clearance on 2021-11-02, under 510(k) number K210473.

Who is the listed applicant for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)?

The FDA product code for Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is EMA.

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Outros registros que listam Imicryl Dis Malzemeleri Sanayi VE Ticaret AS como candidato(a)

K213609NOVA RESIN dual cure, self adhesive resin cement K220077IMICRYL Composite, Composite Flow Materials K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose K192178R&D Series Nova Compo N

Dispositivos Relacionados (Código: EMA)

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Fonte oficial

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