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510(k) K181220

Juell 3D Volo Base by Park Dental Research Corporation — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
May 7, 2018
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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