Clearance Summary
LEVINIUM received FDA 510(k) clearance under submission number K884257, sponsored by Ticomet Engineering & Consulting. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-12-22.
- Submission: K884257
- Applicant / Sponsor: Ticomet Engineering & Consulting
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1988-12-22
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.