Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)— 510(k) K253053

Substantially Equivalent

Hangzhou SHINING3D Dental Technology Co., Ltd.

FDA 510(k) clearance K253053 for Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1), Substantially Equivalent on 2025-09-23. 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: 2025-09-22
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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