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510(k) K193588

DD Contrast by Dental Direkt GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2020
Date Received
December 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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