Clearance Summary
AUROFLUID PLUS received FDA 510(k) clearance under submission number K013505, sponsored by Metalor Technologies USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-12-19.
- Submission: K013505
- Applicant / Sponsor: Metalor Technologies USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2001-12-19
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.