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510(k) K183465

Allcem, Allcem Core by Dentscare Ltda — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2019
Date Received
December 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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