FDA 510(k)

Dental High-speed Turbine Handpiece

Número K: K170229 · 2017-11-08

RequerenteGuangdong Jinme Medical Technology Co., Ltd.

Data da decisão2017-11-08

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental High-speed Turbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-08 under 510(k) number K170229. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental High-speed Turbine Handpiece?

Dental High-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K170229.

When did Dental High-speed Turbine Handpiece receive FDA 510(k) clearance?

Dental High-speed Turbine Handpiece received FDA 510(k) clearance on 2017-11-08, under 510(k) number K170229.

Who is the listed applicant for Dental High-speed Turbine Handpiece?

The FDA 510(k) record lists Guangdong Jinme Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental High-speed Turbine Handpiece?

The FDA product code for Dental High-speed Turbine Handpiece is EFB.

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 Guangdong Jinme Medical Technology Co., Ltd. como candidato(a)

K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)K240340Surgical Drive System (Model: ES70, ES90, E8)K170236Dental Low-speed Turbine Handpiece

Dispositivos Relacionados (Código: EFB)

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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.