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510(k) K242366

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment by Overfibers S.R.L. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
August 9, 2024
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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