FDA 510(k)

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

Número K: K243280 · 2025-07-03

Data da decisão2025-07-03

Código do produtoERL

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) 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 2025-07-03 under 510(k) number K243280. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K243280.

When did Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) receive FDA 510(k) clearance?

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243280.

Who is the listed applicant for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

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 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

The FDA product code for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is ERL.

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

K253776Implantmed Plus II & Piezomed Plus II Module K201703PROXEO Twist Cordless Polishing System PL-40 H K181858Electric Handpiece Motor K171553W&H Assistina Twin

Dispositivos Relacionados (Código: ERL)

K233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SA K213221AMADEO, M-UK1015 (incl. acessórios e peças)W&H Dentalwerk Buermoss GmbH K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc.

Fonte oficial

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