Clearance Summary
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM received FDA 510(k) clearance under submission number K011502, sponsored by Crystal-Seal Dental Implants. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-10-22.
- Submission: K011502
- Applicant / Sponsor: Crystal-Seal Dental Implants
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2001-10-22
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.