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510(k) K252430

Freeprint® denture flex by Detax GmbH — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
August 1, 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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