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510(k) K253053

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) by Hangzhou SHINING3D Dental Technology Co., Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2025
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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