Clearance Summary
JETSONIC 2000 received FDA 510(k) clearance under submission number K014245, sponsored by Deldent , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-01-29.
- Submission: K014245
- Applicant / Sponsor: Deldent , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 2002-01-29
Classification & Regulation
This clearance is catalogued under FDA product code KOJ and 21 CFR 872.6080, within the Dental review panel as a Class II device.