<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04582110799709</udiDi>
    <basicUdiDi>458211076CleanerDJ</basicUdiDi>
    <tradeName>KATANA Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#3970-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:42.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110796371</udiDi>
    <basicUdiDi>458211076Conditioner2157Y</basicUdiDi>
    <tradeName>CLEARFIL CERAMIC PRIMER PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#3637-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:41.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110792700</udiDi>
    <basicUdiDi>458211076Bonding1954U</basicUdiDi>
    <tradeName>CLEARFIL SE BOND 2 Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#3270-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:39.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110792502</udiDi>
    <basicUdiDi>458211076Conditioner1968M</basicUdiDi>
    <tradeName>CLEARFIL DC Activator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#3250-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:37.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110789427</udiDi>
    <basicUdiDi>458211076CoreK7</basicUdiDi>
    <tradeName>CLEARFIL DC CORE PLUS (Dentin)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#2942-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:35.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110786112</udiDi>
    <basicUdiDi>458211076Composite132Z5</basicUdiDi>
    <tradeName>CLEARFIL MAJESTY Flow (A2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#2611-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:35.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110779701</udiDi>
    <basicUdiDi>458211076Bonding0644C</basicUdiDi>
    <tradeName>CLEARFIL SE BOND</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#1970-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:33.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110777219</udiDi>
    <basicUdiDi>458211076Composite017Z4</basicUdiDi>
    <tradeName>CLEARFIL AP-X (A2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#1721-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:31.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110765612</udiDi>
    <basicUdiDi>458211076Composite016Z2</basicUdiDi>
    <tradeName>CLEARFIL PHOTO POSTERIOR US</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#561-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:24.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110763663</udiDi>
    <basicUdiDi>458211076Core1013E</basicUdiDi>
    <tradeName>CLEARFIL PHOTO CORE PLT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#366-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:23.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110760730</udiDi>
    <basicUdiDi>458211076Bonding0233W</basicUdiDi>
    <tradeName>CLEARFIL PHOTO BOND Catalyst Liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#073-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:22.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582110763557</udiDi>
    <basicUdiDi>458211076Core0203D</basicUdiDi>
    <tradeName>CLEARFIL PHOTO CORE (3 syringes)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Kurashiki</manufacturerName>
    <manufacturerSrn>JP-MF-000017326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#355-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:15:20.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04570110513128</udiDi>
    <basicUdiDi>456023117D10B104N001VH</basicUdiDi>
    <tradeName>A・UNO Flow St White</tradeName>
    <deviceName>A・UNO</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A・UNO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:01:46.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560231207143</udiDi>
    <basicUdiDi>456023117D10B102N004UZ</basicUdiDi>
    <tradeName>TMR-AQUA BOND 0 5ml</tradeName>
    <deviceName>TMR-AQUA BOND 0</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMR-AQUA BOND 0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:59:49.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560231206696</udiDi>
    <basicUdiDi>456023117D10B102N003UX</basicUdiDi>
    <tradeName>TMR-ZFill10. Universal A1 3.8g (2ml)</tradeName>
    <deviceName>TMR-Z Fill 10.</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMR-ZFill10.</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:59:48.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560231204579</udiDi>
    <basicUdiDi>456023117D10B102N002UV</basicUdiDi>
    <tradeName>iGOS-BOND 5ml</tradeName>
    <deviceName>iGOS-BOND</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iGOS-BOND</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:59:41.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560231204050</udiDi>
    <basicUdiDi>456023117D10B102N001UT</basicUdiDi>
    <tradeName>iGOS Universal A1 4g (2ml)</tradeName>
    <deviceName>iGOS</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iGOS</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:59:41.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560231203787</udiDi>
    <basicUdiDi>456023117D10B100N003U9</basicUdiDi>
    <tradeName>Multi Primer Paste 2ml</tradeName>
    <deviceName>Multi Primer</deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multi Primer</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:59:37.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260521363039</udiDi>
    <basicUdiDi>426052136DENTAL21FF</basicUdiDi>
    <tradeName>ChairsideCAD 3.1 Rijeka</tradeName>
    <deviceName>ChairsideCAD</deviceName>
    <manufacturerName>exocad GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04260521363039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:04:42.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260296271751</udiDi>
    <basicUdiDi>426029627CEM003XT</basicUdiDi>
    <tradeName>ZENITCEM-Permanent Self Adhesive Luting Cement-1x5ml-Transparent</tradeName>
    <deviceName>ZENITCEM-Permanent Self Adhesive Luting Cement</deviceName>
    <manufacturerName>President Dental GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014901</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD.ZCEM.TRS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:50:51.313Z</lastUpdated>
  </row>
</eudamedExport>