510(k) K261356

Device: Dura-Crown
Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
510(k) number: K261356
Product code: EBF
Decision: Substantially Equivalent (SESE)
Decision date: 2026-04-27
Date received: 2026-04-24
Regulation: 872.3690
Classification name: Material, Tooth Shade, Resin
Medical specialty: Dental
Review panel: Dental
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: Y

Related Records

Applicant Contact

Contact: Jiachen Yang
Address: 9-5-2, Tri-River Valley, Wenyan St., Xiaoshan Hangzhou CN 311258 311258

FDA Registration Numbers

3025307990
3003114027
3008912871
3006805063
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Source Documents

510(k) summary PDF

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