FDA 510(k)

TSV BellaTek Express and BellaTek Flex Abutments

Número K: K192522 · 2019-12-09

Data da decisão2019-12-09

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TSV BellaTek Express and BellaTek Flex Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192522. 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 TSV BellaTek Express and BellaTek Flex Abutments?

TSV BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Biomet 3i, LLC. The 510(k) number is K192522.

When did TSV BellaTek Express and BellaTek Flex Abutments receive FDA 510(k) clearance?

TSV BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192522.

Who is the listed applicant for TSV BellaTek Express and BellaTek Flex Abutments?

The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSV BellaTek Express and BellaTek Flex Abutments?

The FDA product code for TSV BellaTek Express and BellaTek Flex 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 Biomet 3i, LLC como candidato(a)

K251660T3 Pro Implants– ZimVie Packaging System K241753Immediate Molar Implants K241032BellaTek Bars K220978TSX Implants K213672T3 Pro Implants K212730BellaTek Encode Emergence Healing Abutments

Ver todos os 7 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.