<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D661K981</udiDi>
    <basicUdiDi>B-D661K981</basicUdiDi>
    <tradeName>6 Kodex Twist Drills, without Depth-Limitation</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K98</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5021</udiDi>
    <basicUdiDi>B-D661L5021</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Minuta Pink, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5111</udiDi>
    <basicUdiDi>B-D661L5111</basicUdiDi>
    <tradeName>TMS LINK SERIES Complete-Kit, Minikin Red, Gold-Plated Stainless Steel, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L511</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5121</udiDi>
    <basicUdiDi>B-D661L5121</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Minikin Red, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5211</udiDi>
    <basicUdiDi>B-D661L5211</basicUdiDi>
    <tradeName>TMS LINK SERIES Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L521</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5221</udiDi>
    <basicUdiDi>B-D661L5221</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L522</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5311</udiDi>
    <basicUdiDi>B-D661L5311</basicUdiDi>
    <tradeName>TMS LINK SERIES Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L531</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5321</udiDi>
    <basicUdiDi>B-D661L5321</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L532</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5411</udiDi>
    <basicUdiDi>B-D661L5411</basicUdiDi>
    <tradeName>TMS LINK SERIES Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L541</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5421</udiDi>
    <basicUdiDi>B-D661L5421</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L542</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5511</udiDi>
    <basicUdiDi>B-D661L5511</basicUdiDi>
    <tradeName>TMS LINK SERIES Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L551</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L5521</udiDi>
    <basicUdiDi>B-D661L5521</basicUdiDi>
    <tradeName>TMS LINK SERIES Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7211</udiDi>
    <basicUdiDi>B-D661L7211</basicUdiDi>
    <tradeName>TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L721</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7221</udiDi>
    <basicUdiDi>B-D661L7221</basicUdiDi>
    <tradeName>TMS LINK PLUS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L722</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7311</udiDi>
    <basicUdiDi>B-D661L7311</basicUdiDi>
    <tradeName>TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L731</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7321</udiDi>
    <basicUdiDi>B-D661L7321</basicUdiDi>
    <tradeName>TMS LINK PLUS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L732</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7341</udiDi>
    <basicUdiDi>B-D661L7341</basicUdiDi>
    <tradeName>TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L734</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7411</udiDi>
    <basicUdiDi>B-D661L7411</basicUdiDi>
    <tradeName>TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L741</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7421</udiDi>
    <basicUdiDi>B-D661L7421</basicUdiDi>
    <tradeName>TMS LINK PLUS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L742</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661L7511</udiDi>
    <basicUdiDi>B-D661L7511</basicUdiDi>
    <tradeName>TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 20 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L751</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.332Z</lastUpdated>
  </row>
</eudamedExport>