Clearance Summary
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 received FDA 510(k) clearance under submission number K012160, sponsored by Premier Dental Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-09-27.
- Submission: K012160
- Applicant / Sponsor: Premier Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2001-09-27
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.