FDA 510(k)

PROXEO Twist Cordless Polishing System PL-40 H

Número K: K201703 · 2021-02-24

Data da decisão2021-02-24

Código do produtoEKX

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PROXEO Twist Cordless Polishing System PL-40 H is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K201703. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PROXEO Twist Cordless Polishing System PL-40 H?

PROXEO Twist Cordless Polishing System PL-40 H is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K201703.

When did PROXEO Twist Cordless Polishing System PL-40 H receive FDA 510(k) clearance?

PROXEO Twist Cordless Polishing System PL-40 H received FDA 510(k) clearance on 2021-02-24, under 510(k) number K201703.

Who is the listed applicant for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA product code for PROXEO Twist Cordless Polishing System PL-40 H is EKX.

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Outros registros que listam W&H Dentalwerk Buermoos GmbH como candidato(a)

K253776Implantmed Plus II & Piezomed Plus II Module K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)K181858Electric Handpiece Motor K171553W&H Assistina Twin

Dispositivos Relacionados (Código: EKX)

K261987Reusable SmartPegOsstell AB K252223Mão de Ferramentas de Endodontia Alpha (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

Fonte oficial

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