Clearance Summary
iSMILE received FDA 510(k) clearance under submission number K200908, sponsored by 3D Diagnostix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-12-22.
- Submission: K200908
- Applicant / Sponsor: 3D Diagnostix, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2020-12-22
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.