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510(k) K242179

Synea Fusion Handpieces (Intensiv & Profin) by W&H Dentalwerk Bürmoos GmbH — Product Code EFB

K242179 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Bürmoos GmbH for the device "Synea Fusion Handpieces (Intensiv & Profin)". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2025
Date Received
July 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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FDA data resources