Clearance Summary
ITERO SOFTWARE received FDA 510(k) clearance under submission number K131101, sponsored by Cadent, Ltd. an Align Technology Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-08-26.
- Submission: K131101
- Applicant / Sponsor: Cadent, Ltd. an Align Technology Company
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2013-08-26
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.