Clearance Summary
Bonalive Maxillofacial received FDA 510(k) clearance under submission number K253883, sponsored by Bonalive , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-05-14.
- Submission: K253883
- Applicant / Sponsor: Bonalive , Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2026-05-14
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.