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510(k) K220097

PRESIDENT The Original by Coltène/Whaledent AG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2022
Date Received
January 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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