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FDA 510(k)

Synea Fusion Handpieces (Intensiv & Profin)

K-Number: K242179 · 2025-02-28

ApplicantW&H Dentalwerk Bürmoos GmbH
Decision Date2025-02-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Synea Fusion Handpieces (Intensiv & Profin) is a medical device manufactured by W&H Dentalwerk Bürmoos GmbH. It received FDA 510(k) clearance on 2025-02-28 under approval number K242179. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by W&H Dentalwerk Bürmoos GmbH. The 510(k) number is K242179.

When was Synea Fusion Handpieces (Intensiv & Profin) approved by the FDA?

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

What company makes Synea Fusion Handpieces (Intensiv & Profin)?

Synea Fusion Handpieces (Intensiv & Profin) is manufactured by W&H Dentalwerk Bürmoos GmbH.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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