Clearance Summary
Zfx Abutments received FDA 510(k) clearance under submission number K231915, sponsored by Zfx GmbH - A Company of Zimvie. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-03-01.
- Submission: K231915
- Applicant / Sponsor: Zfx GmbH - A Company of Zimvie
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2024-03-01
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.