Clearance Summary
Synea Fusion Handpieces (Intensiv & Profin) received FDA 510(k) clearance under submission number K242179, sponsored by W&H Dentalwerk Bürmoos GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-02-28.
- Submission: K242179
- Applicant / Sponsor: W&H Dentalwerk Bürmoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-02-28
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.