Clearance Summary
Ceramic Brackets Orthometric received FDA 510(k) clearance under submission number K222847, sponsored by Orthometric - Industria E Comercio DE Produtos Medicos. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-05-04.
- Submission: K222847
- Applicant / Sponsor: Orthometric - Industria E Comercio DE Produtos Medicos
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2023-05-04
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.