<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05904433710756</udiDi>
    <basicUdiDi>590443371TF0057E</basicUdiDi>
    <tradeName>NEXT OA2</tradeName>
    <deviceName>NEXT / Arkon Composite/ CiCC/ ESC/ F2/ Monosafe</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:47:35.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433710329</udiDi>
    <basicUdiDi>590443371TF01077</basicUdiDi>
    <tradeName>Masterbond</tradeName>
    <deviceName>Masterbond / New Extra Bond/ Bond</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:47:31.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433718370</udiDi>
    <basicUdiDi>590443371TF0237G</basicUdiDi>
    <tradeName>DEI Clever Fibre Composite Light</tradeName>
    <deviceName>Fibre Composite / Dei Clever Fibre Composite</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:32.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433711876</udiDi>
    <basicUdiDi>590443371TF0227E</basicUdiDi>
    <tradeName>Włókno kompozytowe</tradeName>
    <deviceName>Comcord / Włókno kompozytowe</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</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>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:31.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433711852</udiDi>
    <basicUdiDi>590443371TF0147F</basicUdiDi>
    <tradeName>Perio-Flush</tradeName>
    <deviceName>Perio-flush / Parosin/ Perioactive</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019003</emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:27.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433711579</udiDi>
    <basicUdiDi>590443371TF00278</basicUdiDi>
    <tradeName>FLOW-COLOR WHITE</tradeName>
    <deviceName>FLOW-COLOR / DEI Clever Easyflow</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:26.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433711517</udiDi>
    <basicUdiDi>590443371TF00176</basicUdiDi>
    <tradeName>FLOW-ART A1</tradeName>
    <deviceName>FLOW-ART / DEI Clever Easyflow / Silkflow</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:26.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904433711111</udiDi>
    <basicUdiDi>590443371TF0077J</basicUdiDi>
    <tradeName>Wytrawiacz Stomatologiczny</tradeName>
    <deviceName>Etchgel /  Dei Etching Gel / Wytrawiacz Stomatologiczny/ Etchmaster</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:42:25.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494803</udiDi>
    <basicUdiDi>590443371TF01179</basicUdiDi>
    <tradeName>Podwiązka</tradeName>
    <deviceName>Chords / Podwiązka</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</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>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:28.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494483</udiDi>
    <basicUdiDi>590443371TF0127B</basicUdiDi>
    <tradeName>Shapedchords Internal</tradeName>
    <deviceName>Shapedchords / Gąsienica</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</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>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:27.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494445</udiDi>
    <basicUdiDi>590443371TF0047C</basicUdiDi>
    <tradeName>SEALPRIM</tradeName>
    <deviceName>Sealprim / Lak szczelinowy/ Fissure Sealant</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:26.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494438</udiDi>
    <basicUdiDi>590443371TF0097N</basicUdiDi>
    <tradeName>GLAZE</tradeName>
    <deviceName>Glaze / Boston Glazura/ Boston Glaze</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</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>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:26.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494193</udiDi>
    <basicUdiDi>590443371TF0067G</basicUdiDi>
    <tradeName>Create A1</tradeName>
    <deviceName>Create/ Boston</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:22.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494155</udiDi>
    <basicUdiDi>590443371TF0037A</basicUdiDi>
    <tradeName>Colourant A</tradeName>
    <deviceName>Colourant/ Podbarwiacz/ Colorant</deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:21.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494162</udiDi>
    <basicUdiDi>590443371TF0037A</basicUdiDi>
    <tradeName>Colourant B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494179</udiDi>
    <basicUdiDi>590443371TF0037A</basicUdiDi>
    <tradeName>Colourant C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494186</udiDi>
    <basicUdiDi>590443371TF0037A</basicUdiDi>
    <tradeName>Colourant White</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494209</udiDi>
    <basicUdiDi>590443371TF0067G</basicUdiDi>
    <tradeName>Create A2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494216</udiDi>
    <basicUdiDi>590443371TF0067G</basicUdiDi>
    <tradeName>Create A3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903678494223</udiDi>
    <basicUdiDi>590443371TF0067G</basicUdiDi>
    <tradeName>Create A3.5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk</manufacturerName>
    <manufacturerSrn>PL-MF-000029550</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T09:03:10.151Z</lastUpdated>
  </row>
</eudamedExport>