FDA 510(k)

Composto de Compressão Fluída Apoller Flow

Número K: K180463 · 2018-11-14

Data da decisão2018-11-14

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apoller Flow Light Cure Flowable Composite is the device name listed in this FDA 510(k) record. The listed applicant is Greenway Yw, LLC. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K180463. 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 Apoller Flow Light Cure Flowable Composite?

Apoller Flow Light Cure Flowable Composite is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Greenway Yw, LLC. The 510(k) number is K180463.

When did Apoller Flow Light Cure Flowable Composite receive FDA 510(k) clearance?

Apoller Flow Light Cure Flowable Composite received FDA 510(k) clearance on 2018-11-14, under 510(k) number K180463.

Who is the listed applicant for Apoller Flow Light Cure Flowable Composite?

The FDA 510(k) record lists Greenway Yw, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apoller Flow Light Cure Flowable Composite?

The FDA product code for Apoller Flow Light Cure Flowable Composite is EBF.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.