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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 K170776
Device Name DTI-1 SLA IMPLANT SYSTEM
Applicant
Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi
D1-2 No 5 Merkez Mahallesi
Cekmekoy,  TR 34782
Applicant Contact Fatih Ormeci
Correspondent
Medcer USA
16 Midland Ave.
Hicksville,  NY  11801
Correspondent Contact Fatih Ormeci
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/14/2017
Decision Date 04/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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