Clearance Summary
JEL-20 received FDA 510(k) clearance under submission number K012303, sponsored by J.F. Jelenko & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-08-22.
- Submission: K012303
- Applicant / Sponsor: J.F. Jelenko & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2001-08-22
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.