Clearance Summary
PARAGON IMPLANT SYSTEM received FDA 510(k) clearance under submission number K953101, sponsored by Core-Vent Bio-Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-12-21.
- Submission: K953101
- Applicant / Sponsor: Core-Vent Bio-Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1995-12-21
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.