Clearance Summary
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) received FDA 510(k) clearance under submission number K042345, sponsored by Mondeal Medical Systems GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-01-13.
- Submission: K042345
- Applicant / Sponsor: Mondeal Medical Systems GmbH
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2005-01-13
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.