Clearance Summary
PROPHY ANGLE received FDA 510(k) clearance under submission number K953628, sponsored by Rolence Enterprise Co. , 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 1995-09-29.
- Submission: K953628
- Applicant / Sponsor: Rolence Enterprise Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6290
- Decision date: 1995-09-29
Classification & Regulation
This clearance is catalogued under FDA product code EHK and 21 CFR 872.6290, within the Dental review panel as a Class I device.