Clearance Summary
NEODENT GRAFT SCREW received FDA 510(k) clearance under submission number K103084, sponsored by Jjgc Industria E Comercio DE Materiais Dentarios S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-02-14.
- Submission: K103084
- Applicant / Sponsor: Jjgc Industria E Comercio DE Materiais Dentarios S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2011-02-14
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.