Clearance Summary
SONIC AIR MM1500 + (MID), MODEL 50400014 received FDA 510(k) clearance under submission number K081268, sponsored by Micro-Mega Societe Anonyme. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-08-10.
- Submission: K081268
- Applicant / Sponsor: Micro-Mega Societe Anonyme
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2009-08-10
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.