Clearance Summary
QUANTUM DENTAL IMPLANT SYSTEM received FDA 510(k) clearance under submission number K130787, sponsored by Quantum Bioengineering, 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 2013-06-13.
- Submission: K130787
- Applicant / Sponsor: Quantum Bioengineering, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2013-06-13
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.