Clearance Summary
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 received FDA 510(k) clearance under submission number K070022, sponsored by Mis Implants Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-04-20.
- Submission: K070022
- Applicant / Sponsor: Mis Implants Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2007-04-20
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.