Clearance Summary
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY received FDA 510(k) clearance under submission number K861328, sponsored by Belmont Equipment Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-04-24.
- Submission: K861328
- Applicant / Sponsor: Belmont Equipment Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1986-04-24
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.