Clearance Summary
Tooth Shade Resin Material received FDA 510(k) clearance under submission number K162323, sponsored by Liaoning Upcera 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 2017-01-12.
- Submission: K162323
- Applicant / Sponsor: Liaoning Upcera Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2017-01-12
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.