Clearance Summary
POLO DENTAL UNIT received FDA 510(k) clearance under submission number K854647, sponsored by Alpine Dental Equipment Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-06-05.
- Submission: K854647
- Applicant / Sponsor: Alpine Dental Equipment Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1986-06-05
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.