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510(k) K203641

E-Denture Pro by Envisiontec GmbH — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2021
Date Received
December 14, 2020
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

Other clearances by Envisiontec GmbH

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  • K201173 — E-Guard (November 27, 2020)

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