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510(k) K211916

IPS e.max One by Ivoclar Vivadent, AG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
June 21, 2021
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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