Clearance Summary
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System received FDA 510(k) clearance under submission number K180404, sponsored by 3M Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-03-16.
- Submission: K180404
- Applicant / Sponsor: 3M Healthcare
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2018-03-16
Classification & Regulation
This clearance is catalogued under FDA product code NJM and 21 CFR 872.5470, within the Dental review panel as a Class II device.