<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D661H008221</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC U-shaped Occlusal Rim Wax, 100 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00822</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008251</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Double, 24 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00825</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008261</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Wax Sticks, Scented, 48 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00826</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008271</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Orthodontic Tray Wax, White, 48 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00827</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008370</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing Wax, Regular 2.25 kg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00837</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008380</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing Wax, Extra Fine, 2.25 kg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00838</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008391</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Yellow, Soft, 50 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00839</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H026260</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Yellow Bite Wax Form #19</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H02626</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H033651</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Green, Hard, 50 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H040301</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Double, 24 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661P281</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 12 Proxima Replacement Saw Blades</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:53.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX112S1</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 1000 Medium Pins w/ Split Sleeves</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX112S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX113L0</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex Laser Pinning System, 115V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>PX113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX114S1</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 1000 Long Pins w/ Split Sleeves</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX114S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1151</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 1000 Short Pins and Sleeves</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1161</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 100 Long Pins and Sleeves</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1171</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 100 Short Pins and Sleeves</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1191</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 3 Carbide Drills</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1200</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 1 Reamer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1461</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 3 Flexible Molds</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.755Z</lastUpdated>
  </row>
</eudamedExport>