Clearance Summary
DENTO-PREP PARTICLE MICROBLASTER received FDA 510(k) clearance under submission number K010816, sponsored by Ronvig A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-05-10.
- Submission: K010816
- Applicant / Sponsor: Ronvig A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 2001-05-10
Classification & Regulation
This clearance is catalogued under FDA product code KOJ and 21 CFR 872.6080, within the Dental review panel as a Class II device.