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510(k) K183569

DD cube ONE ML by Dental Direkt GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2019
Date Received
December 21, 2018
Clearance Type
Special
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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