Clearance Summary
NEOCALEX received FDA 510(k) clearance under submission number K013993, sponsored by Stephen M Koral, Dmd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-02-22.
- Submission: K013993
- Applicant / Sponsor: Stephen M Koral, Dmd
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2002-02-22
Classification & Regulation
This clearance is catalogued under FDA product code EIK and 21 CFR 872.4565, within the Dental review panel as a Class I device.