Clearance Summary
EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM received FDA 510(k) clearance under submission number K861502, sponsored by Dr. Harold Bergman. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-06-26.
- Submission: K861502
- Applicant / Sponsor: Dr. Harold Bergman
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1986-06-26
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.