Synea Fusion Handpieces (Intensiv & Profin)

FDA 510(k) K242179 · W&H Dentalwerk Bürmoos GmbH

Substantially Equivalent

510(k) numberK242179

Submission

Device name
Synea Fusion Handpieces (Intensiv & Profin)
Applicant
W&H Dentalwerk Bürmoos GmbH
Buermoos, AT
Received
July 25, 2024
Decision date
February 28, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

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

Synea Fusion Handpieces (Intensiv & Profin) (K242179) received a 510(k) decision of Substantially Equivalent on February 28, 2025, 218 days after the submission was received.

What is the product code of K242179?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.