Clearance Summary
NEW PROPHY POWDER received FDA 510(k) clearance under submission number K014188, sponsored by Dentsply Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-03-15.
- Submission: K014188
- Applicant / Sponsor: Dentsply Intl.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 2002-03-15
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.