Clearance Summary
GEN5 and GEN5+ Dental Implant System received FDA 510(k) clearance under submission number K251938, sponsored by Paragon Implant Mfg., LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-10-30.
- Submission: K251938
- Applicant / Sponsor: Paragon Implant Mfg., LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2025-10-30
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.