FDA 510(k)

NobelProcera HT ML FCZ Implant Bridge and Framework

Número K: K160158 · 2016-07-25

Data da decisão2016-07-25

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NobelProcera HT ML FCZ Implant Bridge and Framework is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K160158. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NobelProcera HT ML FCZ Implant Bridge and Framework?

NobelProcera HT ML FCZ Implant Bridge and Framework is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Nobel Biocare AB. The 510(k) number is K160158.

When did NobelProcera HT ML FCZ Implant Bridge and Framework receive FDA 510(k) clearance?

NobelProcera HT ML FCZ Implant Bridge and Framework received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160158.

Who is the listed applicant for NobelProcera HT ML FCZ Implant Bridge and Framework?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework?

The FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework is NHA.

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 Nobel Biocare AB como candidato(a)

K253988LiteSet Trays K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw K252197Nobel Biocare S Series Implants K243834NobelZygoma TiUltra Implant system K240346NobelProcera Zirconia Implant Bridge K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

Ver todos os 41 dispositivos →

Dispositivos Relacionados (Código: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, 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.