Clearance Summary
Dura-Arch received FDA 510(k) clearance under submission number K261261, sponsored by Hangzhou SHINING3D Dental Technology 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 2026-04-17.
- Submission: K261261
- Applicant / Sponsor: Hangzhou SHINING3D Dental Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2026-04-17
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.