K242179
- 510(k) number
- K242179
- Device name
- Synea Fusion Handpieces (Intensiv & Profin)
- Applicant
- W&H Dentalwerk Bürmoos GmbH AT
- Product code
- EFB — Handpiece, Air-Powered, Dental
- Decision date
- 2025-02-28
- Date received
- 2024-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K242179.pdf
Official FDA record: K242179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.