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<eudamedExport entity="devices">
  <row>
    <udiDi>D661PX1470</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 1 Full Arch Mold</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>PX147</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX1481</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 2 Flexible Molds, Quadrant Left and Right</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>PX148</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX2011</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 12 Pindex Replacement Blades - 0.007</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>PX201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX2021</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 12 Pindex Replacement Blades - 0.010</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>PX202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX3011</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 100 Pindex Replacement Blades - 0.007</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>PX301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661PX3021</udiDi>
    <basicUdiDi>++D661019KN</basicUdiDi>
    <tradeName>Pindex System 100 Pindex Replacement Blades - 0.010</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>PX302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC1530</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC50 600ml Beaker with Cover</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC153</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC300230CE0</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300-230V Ultrasonic Cleaner</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC300230CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC300230UK0</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300-UK Ultrasonic Cleaner</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC300230UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3100</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Large FingerGuard Instrument Basket</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC311</udiDi>
    <basicUdiDi>++D661082KV</basicUdiDi>
    <tradeName>BioSonic General Purpose Cleaning Solution</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>D0899</emdnCode>
    <emdnDescription>DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3110</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Twin FingerGuard Instrument Basket</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC320</udiDi>
    <basicUdiDi>++D661082KV</basicUdiDi>
    <tradeName>BioSonic Enzymatic Ultrasonic Cleaning Solution Concentrate</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>D0899</emdnCode>
    <emdnDescription>DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3250</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Cassette Basket for IMS Cassettes</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3300</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Two Beaker Holder</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3351</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Basket Section Inserts</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC335</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3501</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Replacement Drain Filters</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC3550</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC300 Drain Hose</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC355</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC50DB230CE0</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC50 230V Ultrasonic Cleaner with CE Line Cord</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC50DB230CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661UC50DB230UK0</udiDi>
    <basicUdiDi>++D661043KK</basicUdiDi>
    <tradeName>UC50 230V Ultrasonic Cleaner with UK Line Cord</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>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UC50DB230UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:45.581Z</lastUpdated>
  </row>
</eudamedExport>