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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K233419
Device Name GBR System
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
Dudullu Osb Mahallesi Imes Sanayi Sitesi E Blok 501. Sokak N
O:25 Dudullu Osb Mahallesi Imes Sanayi Sitesi C Blok 305.
Istanbul,  TR 34775
Correspondent Contact Hakan Cevik
Regulation Number872.4880
Classification Product Code
DZL  
Date Received10/10/2023
Decision Date 01/03/2025
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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