FDA 510(k)

Southern Implants PEEK Abutments

Número K: K172160 · 2018-02-09

Data da decisão2018-02-09

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Southern Implants PEEK Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172160. 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 Southern Implants PEEK Abutments?

Southern Implants PEEK Abutments is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K172160.

When did Southern Implants PEEK Abutments receive FDA 510(k) clearance?

Southern Implants PEEK Abutments received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172160.

Who is the listed applicant for Southern Implants PEEK Abutments?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Southern Implants PEEK Abutments?

The FDA product code for Southern Implants PEEK Abutments 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 Southern Implants (Pty), Ltd. como candidato(a)

K232726External Hex Implant System K232418Single Platform SP1 Implant System K230873Canal de Parafuso Angulado (ASC) Solução de Pilares e Pilares SI-BASE K222469TIB Abutments K222457Sistema de Implante Provata K222497Zaga Zygomatic System

Ver todos os 19 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.