<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>E165600195622</udiDi>
    <basicUdiDi>++E165ENDO1GFBX002A8</basicUdiDi>
    <tradeName>roeko GuttaFlow bioseal Mixing Tips, 24 pcs.</tradeName>
    <deviceName>GuttaFlow bioseal Mix.Tips</deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60019562</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:30:37.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>E165600195610</udiDi>
    <basicUdiDi>++E165ENDO1GFBX001A6</basicUdiDi>
    <tradeName>roeko GuttaFlow bioseal Refill Applicator</tradeName>
    <deviceName>GuttaFlow bioseal Refill Applicator</deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60019561</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:30:36.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>E165600195600</udiDi>
    <basicUdiDi>++E165ENDO1GFBXK0017T</basicUdiDi>
    <tradeName>roeko GuttaFlow bioseal Standard Set</tradeName>
    <deviceName>GuttaFlow bioseal Standard Set</deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60019560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:30:35.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>E165600137192</udiDi>
    <basicUdiDi>++E165ENDO1GF2X00253</basicUdiDi>
    <tradeName>roeko GuttaFlow2 Mixing Tips, 24 pcs.</tradeName>
    <deviceName>GuttaFlow2 Mixing Tips</deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013719</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:30:35.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D9674004503</udiDi>
    <basicUdiDi>++D967EMTF023L</basicUdiDi>
    <tradeName>Citrogen Gel</tradeName>
    <deviceName>Endodontic Material</deviceName>
    <manufacturerName>PREVEST DENPRO LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000011546</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:18:41.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D73541400000020</udiDi>
    <basicUdiDi>++D735CalciumHydroxPastJ9</basicUdiDi>
    <tradeName>ALPHA-CAL, CALCIUM HYDROXIDE PASTE 4 X 1g KIT</tradeName>
    <deviceName>Calcium Hydroxide Paste</deviceName>
    <manufacturerName>Dental Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027130</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>414-0000-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:07:05.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D099B00GSIQ000BAS0</udiDi>
    <basicUdiDi>++D099endotherapydeviceL2</basicUdiDi>
    <tradeName>Dentsply Sirona</tradeName>
    <deviceName>CORDLESS OBTURATION SYSTEM, GUTTA SMART - ROW</deviceName>
    <manufacturerName>Aseptico, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014012</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B00GSIQ000BAS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:20:51.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35330</udiDi>
    <basicUdiDi>++B961DDPD3533LG</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 13</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 13</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-533</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:33.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35320</udiDi>
    <basicUdiDi>++B961DDPD3532LE</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 12</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 12</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-532</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:32.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35310</udiDi>
    <basicUdiDi>++B961DDPD3531LC</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 11</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 11</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-531</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:32.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35300</udiDi>
    <basicUdiDi>++B961DDPD3530LA</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 10</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 10</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-530</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:24.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35290</udiDi>
    <basicUdiDi>++B961DDPD3529LR</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 179</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 179</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-529</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:20.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35280</udiDi>
    <basicUdiDi>++B961DDPD3528LP</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 6</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 6</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-528</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:19.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35260</udiDi>
    <basicUdiDi>++B961DDPD3526LK</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS PF1</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS PF1</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-526</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:17.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35270</udiDi>
    <basicUdiDi>++B961DDPD3527LM</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS 11</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS 11</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-527</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:15.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35220</udiDi>
    <basicUdiDi>++B961DDPD3522LB</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS   HEIDEMANN SPATULAS 1</tradeName>
    <deviceName>FILLING INSTRUMENTS   HEIDEMANN SPATULAS 1</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-522</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:13.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35250</udiDi>
    <basicUdiDi>++B961DDPD3525LH</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS SPATULAS PF1A</tradeName>
    <deviceName>FILLING INSTRUMENTS SPATULAS PF1A</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-525</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:52:13.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35210</udiDi>
    <basicUdiDi>++B961DDPD3521L9</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 9</tradeName>
    <deviceName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 9</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-521</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:51:57.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35200</udiDi>
    <basicUdiDi>++B961DDPD3520L7</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 8</tradeName>
    <deviceName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 8</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-520</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:51:56.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>B961DDPD35190</udiDi>
    <basicUdiDi>++B961DDPD3519LN</basicUdiDi>
    <tradeName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 7</tradeName>
    <deviceName>FILLING INSTRUMENTS ENAMEL INSTRUMENTS CHISELS 7</deviceName>
    <manufacturerName>Daddy D Pro</manufacturerName>
    <manufacturerSrn>PK-MF-000035172</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDP-D3-519</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:51:54.935Z</lastUpdated>
  </row>
</eudamedExport>