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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K231100
Device Name Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Applicant
Proimtech Saglik Urunleri Anonim Sirketi
Imes Sitesi, No:3 Dudullu Osb Mahallesi Imes 305.Sokak
Istanbul,  TR 34773
Applicant Contact Hakan Cevik
Correspondent
Proimtech Saglik Urunleri Anonim Sirketi
Imes Sitesi, No:3 Dudullu Osb Mahallesi Imes 305.Sokak
Istanbul,  TR 34773
Correspondent Contact Hakan Cevik
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/18/2023
Decision Date 08/23/2024
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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