FDA 510(k)

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

Número K: K232233 · 2023-09-26

Data da decisão2023-09-26

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K232233. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Align Technology, Inc.. The 510(k) number is K232233.

When did Invisalign System with Mandibular Advancement Featuring Occlusal Blocks receive FDA 510(k) clearance?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks received FDA 510(k) clearance on 2023-09-26, under 510(k) number K232233.

Who is the listed applicant for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

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

What is the FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is NXC.

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 Align Technology, Inc. como candidato(a)

K262196Invisalign System K252931Invisalign® Palatal Expander System K252870Invisalign Specifix Attachment System K252380Invisalign System K241412Invisalign System K232887Invisalign Palatal Expander System

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: NXC)

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

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.