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510(k) K250489

FP3D by Keystone Industries — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2025
Date Received
February 19, 2025
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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