FDA 510(k)

Toothsi, Smilealigners

Número K: K223338 · 2023-02-09

RequerenteMakeo Healthcare Technologies Private Limited

Data da decisão2023-02-09

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Toothsi, Smilealigners is the device name listed in this FDA 510(k) record. The listed applicant is Makeo Healthcare Technologies Private Limited. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K223338. 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 Toothsi, Smilealigners?

Toothsi, Smilealigners is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Makeo Healthcare Technologies Private Limited. The 510(k) number is K223338.

When did Toothsi, Smilealigners receive FDA 510(k) clearance?

Toothsi, Smilealigners received FDA 510(k) clearance on 2023-02-09, under 510(k) number K223338.

Who is the listed applicant for Toothsi, Smilealigners?

The FDA 510(k) record lists Makeo Healthcare Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Toothsi, Smilealigners?

The FDA product code for Toothsi, Smilealigners 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

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.