Clearance Summary
JELDENT BASIC LINE received FDA 510(k) clearance under submission number K000213, sponsored by J.F. Jelenko & 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 2000-04-06.
- Submission: K000213
- Applicant / Sponsor: J.F. Jelenko & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 2000-04-06
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.