Clearance Summary
FOUNDATION DENTAL RESIN received FDA 510(k) clearance under submission number K111709, sponsored by Unix-Japan Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-11-18.
- Submission: K111709
- Applicant / Sponsor: Unix-Japan Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2011-11-18
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.