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510(k) K191497

NextDent Denture 3D+ by Vertex-Dental B.V. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2019
Date Received
June 5, 2019
Clearance Type
Abbreviated
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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