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510(k) K250497

Additive Manufacturing (Light Curing) Crown Bridge Resin by Aidite (Qinhuangdao) Technology Co., Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2025
Date Received
February 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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