Clearance Summary
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS received FDA 510(k) clearance under submission number K113334, sponsored by Opal Orthodontics by Ultradent Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-02-03.
- Submission: K113334
- Applicant / Sponsor: Opal Orthodontics by Ultradent Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2012-02-03
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.