Clearance Summary
OPTIMA MX received FDA 510(k) clearance under submission number K042759, sponsored by Bien-Air SA Switzerland. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-10-20.
- Submission: K042759
- Applicant / Sponsor: Bien-Air SA Switzerland
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2004-10-20
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.