Dura-Arch— 510(k) K261261

Substantially Equivalent

Hangzhou SHINING3D Dental Technology Co., Ltd.

FDA 510(k) clearance K261261 for Dura-Arch, Substantially Equivalent on 2026-04-17. Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd..

Clearance details

Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
Product code: Code EBG
Advisory panel: Dental
Date received: 2026-04-16
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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