FDA 510(k)

Synea Fusion Handpieces (Intensiv & Profin)

Número K: K242179 · 2025-02-28

Data da decisão2025-02-28

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synea Fusion Handpieces (Intensiv & Profin) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Bürmoos GmbH. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K242179. 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 Synea Fusion Handpieces (Intensiv & Profin)?

Synea Fusion Handpieces (Intensiv & Profin) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is W&H Dentalwerk Bürmoos GmbH. The 510(k) number is K242179.

When did Synea Fusion Handpieces (Intensiv & Profin) receive FDA 510(k) clearance?

Synea Fusion Handpieces (Intensiv & Profin) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242179.

Who is the listed applicant for Synea Fusion Handpieces (Intensiv & Profin)?

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

What is the FDA product code for Synea Fusion Handpieces (Intensiv & Profin)?

The FDA product code for Synea Fusion Handpieces (Intensiv & Profin) is EFB.

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