FDA 510(k)

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

Número K: K222741 · 2022-11-07

Data da decisão2022-11-07

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is the device name listed in this FDA 510(k) record. The listed applicant is Hdi, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222741. 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 DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Hdi, Inc.. The 510(k) number is K222741.

When did DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) receive FDA 510(k) clearance?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222741.

Who is the listed applicant for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

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

What is the FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

The FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) 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 Hdi, Inc. como candidato(a)

K213339DENU Composite Resin, DENU Flow Resin

Dispositivos Relacionados (Código: ELW)

K254142Dia-X Sil Heavy BodyDiaDent Group International K254152Dia-X Sil Light 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.