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510(k) K243103

Denture Base by Riton 3D Technology Co., Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2024
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

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