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510(k) K233171

PF Keep; Cad Cam Keep Block by Clemde SA DE CV — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
September 28, 2023
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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