Clearance Summary
FIBREKOR POST SYSTEM received FDA 510(k) clearance under submission number K983266, sponsored by Jeneric/Pentron, 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 1998-11-09.
- Submission: K983266
- Applicant / Sponsor: Jeneric/Pentron, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 1998-11-09
Classification & Regulation
This clearance is catalogued under FDA product code ELR and 21 CFR 872.3810, within the Dental review panel as a Class I device.