Clearance Summary
Lumina-PTFE Titanium received FDA 510(k) clearance under submission number K221851, sponsored by Criteria Industria E Comercio DE Produtos Medicinais. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-12-08.
- Submission: K221851
- Applicant / Sponsor: Criteria Industria E Comercio DE Produtos Medicinais
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2023-12-08
Classification & Regulation
This clearance is catalogued under FDA product code NPK and 21 CFR 872.3930, within the Dental review panel as a Class II device.