Clearance Summary
TRIMIRA OCS 3000 received FDA 510(k) clearance under submission number K082603, sponsored by Remicalm, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-12-12.
- Submission: K082603
- Applicant / Sponsor: Remicalm, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6350
- Decision date: 2008-12-12
Classification & Regulation
This clearance is catalogued under FDA product code NXV and 21 CFR 872.6350, within the Dental review panel as a Class II device.