Clearance Summary
ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY received FDA 510(k) clearance under submission number K863028, sponsored by Ross Implant Technologies Corp., 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 1986-10-06.
- Submission: K863028
- Applicant / Sponsor: Ross Implant Technologies Corp., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1986-10-06
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.