Dura-Crown— 510(k) K261356

Substantially Equivalent

Hangzhou SHINING3D Dental Technology Co., Ltd.

FDA 510(k) clearance K261356 for Dura-Crown, Substantially Equivalent on 2026-04-27. Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd..

Clearance details

Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
Product code: Code EBF
Advisory panel: Dental
Date received: 2026-04-24
Decision date: 2026-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou, CN

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