Clearance Summary
FIAD EXPLOR-X; MODEL 70 KVP received FDA 510(k) clearance under submission number K871051, sponsored by United States Dental. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-05-04.
- Submission: K871051
- Applicant / Sponsor: United States Dental
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 1987-05-04
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.