<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07640168186944</udiDi>
    <basicUdiDi>B-07640168186944</basicUdiDi>
    <tradeName>i-system Multi Unit Abutment</tradeName>
    <deviceName>i-system Multi Unit Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SMUA5050(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:33:03.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186937</udiDi>
    <basicUdiDi>B-07640168186937</basicUdiDi>
    <tradeName>i-system Multi Unit Abutment</tradeName>
    <deviceName>i-system Multi Unit Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SMUA4050(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:33:01.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186920</udiDi>
    <basicUdiDi>B-07640168186920</basicUdiDi>
    <tradeName>i-system Multi Unit Abutment</tradeName>
    <deviceName>i-system Multi Unit Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SMUA3050(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:58.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186913</udiDi>
    <basicUdiDi>B-07640168186913</basicUdiDi>
    <tradeName>i-system Multi Unit Abutment</tradeName>
    <deviceName>i-system Multi Unit Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SMUA2050(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:57.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186906</udiDi>
    <basicUdiDi>B-07640168186906</basicUdiDi>
    <tradeName>i-system Multi Unit Abutment</tradeName>
    <deviceName>i-system Multi Unit Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SMUA1050(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:56.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186890</udiDi>
    <basicUdiDi>B-07640168186890</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA60(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:55.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186883</udiDi>
    <basicUdiDi>B-07640168186883</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA50(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:53.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186876</udiDi>
    <basicUdiDi>B-07640168186876</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA40(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:50.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186869</udiDi>
    <basicUdiDi>B-07640168186869</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA30(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:49.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186852</udiDi>
    <basicUdiDi>B-07640168186852</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA20(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:48.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186845</udiDi>
    <basicUdiDi>B-07640168186845</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA10(3)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:46.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186838</udiDi>
    <basicUdiDi>B-07640168186838</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA60(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:44.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186821</udiDi>
    <basicUdiDi>B-07640168186821</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA50(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:43.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186814</udiDi>
    <basicUdiDi>B-07640168186814</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA40(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:41.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186784</udiDi>
    <basicUdiDi>B-07640168186784</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA10(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:39.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186807</udiDi>
    <basicUdiDi>B-07640168186807</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA30(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:37.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186791</udiDi>
    <basicUdiDi>B-07640168186791</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA20(2.5)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:37.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186777</udiDi>
    <basicUdiDi>B-07640168186777</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA60(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:35.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186760</udiDi>
    <basicUdiDi>B-07640168186760</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA50(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:20.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640168186753</udiDi>
    <basicUdiDi>B-07640168186753</basicUdiDi>
    <tradeName>i-system Ball Abutment</tradeName>
    <deviceName>i-system Ball Abutment</deviceName>
    <manufacturerName>Novodent SA</manufacturerName>
    <manufacturerSrn>CH-MF-000023309</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-SBA40(2)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:32:19.488Z</lastUpdated>
  </row>
</eudamedExport>