FDA 510(k)

S.I.N. Implant System

Número K: K170392 · 2017-12-01

RequerenteS.I.N. – Sistema DE Implante Nacional S.A.

Data da decisão2017-12-01

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

S.I.N. Implant System is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K170392. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the S.I.N. Implant System?

S.I.N. Implant System is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. The 510(k) number is K170392.

When did S.I.N. Implant System receive FDA 510(k) clearance?

S.I.N. Implant System received FDA 510(k) clearance on 2017-12-01, under 510(k) number K170392.

Who is the listed applicant for S.I.N. Implant System?

The FDA 510(k) record lists S.I.N. – Sistema DE Implante Nacional S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.I.N. Implant System?

The FDA product code for S.I.N. Implant System is DZE.

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 S.I.N. – Sistema DE Implante Nacional S.A. como candidato(a)

K240609S.I.N. Dental Implant System K241378S.I.N. Instrument Kits K232821S.I.N. Dental Implant System K231127S.I.N. Dental Implant System K230069S.I.N. Dental Implant System K221453S.I.N. Dental Implant System

Ver todos os 17 dispositivos →

Dispositivos Relacionados (Código: DZE)

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC K260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.