Clearance Summary
PROPHY PRO. received FDA 510(k) clearance under submission number K945834, sponsored by Hyman, Phelps & McNamara, P.C.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-02-13.
- Submission: K945834
- Applicant / Sponsor: Hyman, Phelps & McNamara, P.C.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1995-02-13
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.