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510(k) K254063

iCEM Universal Plus by Kulzer, LLC — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
December 17, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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