Clearance Summary
TF ROTARY NICKEL TITANIUM FILE received FDA 510(k) clearance under submission number K062856, sponsored by Ormco Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-12-13.
- Submission: K062856
- Applicant / Sponsor: Ormco Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2006-12-13
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.