Clearance Summary
VERICORE IMPLANT ABUTMENTS received FDA 510(k) clearance under submission number K082299, sponsored by Whip-Mix Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-11-20.
- Submission: K082299
- Applicant / Sponsor: Whip-Mix Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2008-11-20
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.