Clearance Summary
PROPHYPEARLS received FDA 510(k) clearance under submission number K031868, sponsored by Kavo America. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-07-09.
- Submission: K031868
- Applicant / Sponsor: Kavo America
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2003-07-09
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.