FDA 510(k)

HySil Impression Materials

Número K: K181236 · 2018-09-13

Data da decisão2018-09-13

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

HySil Impression Materials is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K181236. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HySil Impression Materials?

HySil Impression Materials is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K181236.

When did HySil Impression Materials receive FDA 510(k) clearance?

HySil Impression Materials received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181236.

Who is the listed applicant for HySil Impression Materials?

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

What is the FDA product code for HySil Impression Materials?

The FDA product code for HySil Impression Materials is ELW.

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

Outros registros que listam Osstem Implant Co., Ltd. como candidato(a)

K251434Healing Abutment System K251569Bone Screw K242521Estar-ZE K233806T2 Plus K233194TS Abutment System K232220SS Abutment System

Ver todos os 31 dispositivos →

Dispositivos Relacionados (Código: ELW)

K254152Dia-X Sil Light BodyDiaDent Group International K254142Dia-X Sil Heavy BodyDiaDent Group International K254112Dia-X Sil BiteDiaDent Group International K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio Ltda K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AG K241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

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.