Nucleoss T6 Dental Implant System

Implant, Endosseous, Root-form

Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St

The following data is part of a premarket notification filed by Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St with the FDA for Nucleoss T6 Dental Implant System.

Pre-market Notification Details

Device IDK192062
510k NumberK192062
Device Name:Nucleoss T6 Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St 10018 Sok. No 7. ITOB Sanayi Bölgesi Tekeli Menderes Izmir,  TR 35477
ContactEzgi Ozbudak
CorrespondentSemih Oktay
CardioMed Device Consultants 3168 Braverton St., Suite 200 Edgewater,  MD  21037
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-01
Decision Date2020-08-27

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