FDA 510(k)

Erran Dental Zirconia

Número K: K182068 · 2018-12-13

RequerenteHangzhou Erran Technology Co., Ltd.

Data da decisão2018-12-13

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Erran Dental Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Erran Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182068. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Erran Dental Zirconia?

Erran Dental Zirconia is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Hangzhou Erran Technology Co., Ltd.. The 510(k) number is K182068.

When did Erran Dental Zirconia receive FDA 510(k) clearance?

Erran Dental Zirconia received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182068.

Who is the listed applicant for Erran Dental Zirconia?

The FDA 510(k) record lists Hangzhou Erran Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erran Dental Zirconia?

The FDA product code for Erran Dental Zirconia is EIH.

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: EIH)

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.

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.