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510(k) K230410

DD medical polymers (PMMA) by Dental Direkt GmbH — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
February 15, 2023
Clearance Type
Special
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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