Clearance Summary
BRANEMARK INTEGRATION BIOHELIX IMPLANTS received FDA 510(k) clearance under submission number K090005, sponsored by Branemark Integration AB. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-05-19.
- Submission: K090005
- Applicant / Sponsor: Branemark Integration AB
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2009-05-19
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.