Clearance Summary
ELEMENTS DIAGNOSTIC UNIT received FDA 510(k) clearance under submission number K021298, sponsored by Sybron Endo/Analytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-06-19.
- Submission: K021298
- Applicant / Sponsor: Sybron Endo/Analytic
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1720
- Decision date: 2002-06-19
Classification & Regulation
This clearance is catalogued under FDA product code EAT and 21 CFR 872.1720, within the Dental review panel as a Class II device.