Clearance Summary
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE received FDA 510(k) clearance under submission number K102641, sponsored by Neoortho Produtos Ortopedicos S/A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-12-20.
- Submission: K102641
- Applicant / Sponsor: Neoortho Produtos Ortopedicos S/A
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2010-12-20
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.