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<eudamedExport entity="devices">
  <row>
    <udiDi>D661C79702302400</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Light Curing System, 230/240V</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>C7970230240</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C7970230240C0</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Light Curing System, 230/240V China</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>C7970230240C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C7970RK10</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Charger Base w/ Power Supply, Domestic Units</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>C7970RK1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C7970RK20</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Charger Base w/ Power Supply, International Units</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>C7970RK2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C79721</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Press-On Light Lens, 25 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>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7972</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C79741</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Screw-On Light Lens, 25 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>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7974</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661C79901</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>Coltolux LED Snap-On Light Shield, 13 mm, 25 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>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C7990</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008050</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Red Wax, 450 g</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>H00805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008060</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Medium Soft, #3 Pink Wax, 450 g</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>H00806</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008070</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Yellow Bite Wax, 450 g</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>H00807</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008090</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Extra Tough Wax, 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>H00809</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008110</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Red Wax, 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>H00811</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008120</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Medium Soft, #3 Pink Wax, 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>H00812</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008130</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Yellow Bite Wax, 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>H00813</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008150</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing Wax, Regular, 450 g</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>H00815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008160</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing wax, Extra Fine, 450 g</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>H00816</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008171</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Round Wax Strips, Red, 80 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>H00817</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008181</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Round Wax Strips, White, 80 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>H00818</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008191</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Square Wax Ropes, Red</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>H00819</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008201</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Square Wax Ropes, White</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>H00820</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.079Z</lastUpdated>
  </row>
</eudamedExport>