Clearance Summary
INTRAOS 70 received FDA 510(k) clearance under submission number K031118, sponsored by Blue X Imaging Srl. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-07-08.
- Submission: K031118
- Applicant / Sponsor: Blue X Imaging Srl
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2003-07-08
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.