Clearance Summary
MICROSCOPE SYSTEM received FDA 510(k) clearance under submission number K041805, sponsored by Miras Mirror Imaging Solutions, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-09-21.
- Submission: K041805
- Applicant / Sponsor: Miras Mirror Imaging Solutions, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2004-09-21
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.