Clearance Summary
INTER-OS BONE GENERATOR received FDA 510(k) clearance under submission number K993869, sponsored by Inter-Os Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-01-19.
- Submission: K993869
- Applicant / Sponsor: Inter-Os Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2000-01-19
Classification & Regulation
This clearance is catalogued under FDA product code MQN and 21 CFR 872.4760, within the Dental review panel as a Class II device.