Clearance Summary
Osstell IDx received FDA 510(k) clearance under submission number K142358, sponsored by Osstell AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-02-19.
- Submission: K142358
- Applicant / Sponsor: Osstell AB
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2015-02-19
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.