Clearance Summary
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) received FDA 510(k) clearance under submission number K200555, sponsored by Prevest Denpro Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-05-13.
- Submission: K200555
- Applicant / Sponsor: Prevest Denpro Limited
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2021-05-13
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.