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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K242366
Device Name OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
Applicant
Overfibers S.R.L.
Via Malatesta,7
Imola (Bo),  IT 40026
Applicant Contact Castrenze Genovese
Correspondent
Overfibers S.R.L.
Via Malatesta,7
Imola (Bo),  IT 40026
Correspondent Contact Castrenze Genovese
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/09/2024
Decision Date 01/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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