Clearance Summary
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT received FDA 510(k) clearance under submission number K101005, sponsored by Astra Tech 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 2011-06-21.
- Submission: K101005
- Applicant / Sponsor: Astra Tech AB
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2011-06-21
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.