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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, Orthodontic
510(k) Number K231502
Device Name Mini Screws
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
OAT  
Date Received05/24/2023
Decision Date 09/04/2024
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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