Clearance Summary
ORTHOPHOS 3/ ORTHOPHOS 3C received FDA 510(k) clearance under submission number K936068, 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 1994-07-29.
- Submission: K936068
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1994-07-29
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.