Cleared Traditional

Synea Fusion Handpieces (Intensiv & Profin)

K242179 · W&H Dentalwerk B?rmoos GmbH · Dental
Feb 2025
Decision
218d
Days
Class 1
Risk

About This 510(k) Submission

K242179 is an FDA 510(k) clearance for the Synea Fusion Handpieces (Intensiv & Profin), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by W&H Dentalwerk B?rmoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on February 28, 2025, 218 days after receiving the submission on July 25, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K242179 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2024
Decision Date February 28, 2025
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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