Clearance Summary
ELITY 70 X-RAY received FDA 510(k) clearance under submission number K043136, sponsored by Dental X-Ray E.U.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-01-06.
- Submission: K043136
- Applicant / Sponsor: Dental X-Ray E.U.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2005-01-06
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.