Clearance Summary
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC received FDA 510(k) clearance under submission number K983161, sponsored by Sabre-K , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-09-30.
- Submission: K983161
- Applicant / Sponsor: Sabre-K , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 1998-09-30
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.