Clearance Summary
PROANGLE DISPOSABLE PROPHY ANGLE received FDA 510(k) clearance under submission number K030603, sponsored by Pac-Dent International (Suzhou), Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-04-14.
- Submission: K030603
- Applicant / Sponsor: Pac-Dent International (Suzhou), Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2003-04-14
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.