Clearance Summary
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K123419, sponsored by Afp Imaging Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-12-27.
- Submission: K123419
- Applicant / Sponsor: Afp Imaging Corp.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2012-12-27
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.