FDA 510(k)

MultiMatch Flow Chameleon AntiMicrobial Composite

Número K: K253513 · 2025-11-07

RequerentePremier Dental Products Company

Data da decisão2025-11-07

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MultiMatch Flow Chameleon AntiMicrobial Composite is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Company. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K253513. 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 MultiMatch Flow Chameleon AntiMicrobial Composite?

MultiMatch Flow Chameleon AntiMicrobial Composite is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Premier Dental Products Company. The 510(k) number is K253513.

When did MultiMatch Flow Chameleon AntiMicrobial Composite receive FDA 510(k) clearance?

MultiMatch Flow Chameleon AntiMicrobial Composite received FDA 510(k) clearance on 2025-11-07, under 510(k) number K253513.

Who is the listed applicant for MultiMatch Flow Chameleon AntiMicrobial Composite?

The FDA 510(k) record lists Premier Dental Products Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiMatch Flow Chameleon AntiMicrobial Composite?

The FDA product code for MultiMatch Flow Chameleon AntiMicrobial Composite is EBF.

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Outros registros que listam Premier Dental Products Company como candidato(a)

K260682Bond-PR™ Universal Adhesive K223632Premier's MultiMatch Universal Chameleon Restorative Composite

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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