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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 K192062
Device Name Nucleoss T6 Dental Implant System
Applicant
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
10018 Sok. No 7. Itob Sanayi Bölgesi Tekeli Menderes
Izmir,  TR 35477
Applicant Contact Ezgi Ozbudak
Correspondent
Cardiomed Device Consultants
3168 Braverton St.
Suite 200
Edgewater,  MD  21037
Correspondent Contact Semih Oktay
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/01/2019
Decision Date 08/27/2020
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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