Clearance Summary
HELIODENT MD received FDA 510(k) clearance under submission number K950030, sponsored by Pelton & Crane 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 1995-02-03.
- Submission: K950030
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1995-02-03
Classification & Regulation
This clearance is catalogued under FDA product code EAP and 21 CFR 872.1810, within the Dental review panel as a Class II device.