FDA 510(k)

Lotus Prophy Angle

Número K: K220346 · 2022-11-07

Data da decisão2022-11-07

Código do produtoEGS

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lotus Prophy Angle is the device name listed in this FDA 510(k) record. The listed applicant is Ajk Engineering, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K220346. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lotus Prophy Angle?

Lotus Prophy Angle is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Ajk Engineering, Inc.. The 510(k) number is K220346.

When did Lotus Prophy Angle receive FDA 510(k) clearance?

Lotus Prophy Angle received FDA 510(k) clearance on 2022-11-07, under 510(k) number K220346.

Who is the listed applicant for Lotus Prophy Angle?

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

What is the FDA product code for Lotus Prophy Angle?

The FDA product code for Lotus Prophy Angle is EGS.

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: EGS)

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited K240950Disposable Prophy AnglePacific Care Limited K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division K230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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.