<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D661TFT151</udiDi>
    <basicUdiDi>B-D661TFT151</basicUdiDi>
    <tradeName>5 Tenax Fiber Trans Posts, 1.5mm</tradeName>
    <deviceName>Tenax Fiber Trans</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFT15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:41.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TFT131</udiDi>
    <basicUdiDi>B-D661TFT131</basicUdiDi>
    <tradeName>5 Tenax Fiber Trans Posts, 1.3mm</tradeName>
    <deviceName>Tenax Fiber Trans</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFT13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:40.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TFT11B1</udiDi>
    <basicUdiDi>B-D661TFT11B1</basicUdiDi>
    <tradeName>100 Tenax Fiber Trans Posts, 1.1mm</tradeName>
    <deviceName>Tenax Fiber Trans</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFT11B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:38.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TFT111</udiDi>
    <basicUdiDi>B-D661TFT111</basicUdiDi>
    <tradeName>5 Tenax Fiber Trans Posts, 1.1mm</tradeName>
    <deviceName>Tenax Fiber Trans</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFT11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:36.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TFT11</udiDi>
    <basicUdiDi>B-D661TFT11</basicUdiDi>
    <tradeName>Tenax Fiber Trans Intro Kit</tradeName>
    <deviceName>Tenax Fiber Trans</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFT1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:34.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEDC11</udiDi>
    <basicUdiDi>B-D661TEDC11</basicUdiDi>
    <tradeName>ParaPost Starter Drill and Universal Hand Driver</tradeName>
    <deviceName>ParaPost Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEDC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:33.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TED151</udiDi>
    <basicUdiDi>B-D661TED151</basicUdiDi>
    <tradeName>3 TENAX Fiber Trans Drills 1.5mm</tradeName>
    <deviceName>Tenax Fiber Trans Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TED15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:32.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TED131</udiDi>
    <basicUdiDi>B-D661TED131</basicUdiDi>
    <tradeName>3 TENAX Fiber Trans Drills 1.3mm</tradeName>
    <deviceName>Tenax Fiber Trans Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TED13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:29.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TED111</udiDi>
    <basicUdiDi>B-D661TED111</basicUdiDi>
    <tradeName>3 TEANX Fiber Trans Drills 1.1mm</tradeName>
    <deviceName>Tenax Fiber Trans Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TED11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:28.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEA151</udiDi>
    <basicUdiDi>B-D661TEA151</basicUdiDi>
    <tradeName>3 TENAX Drills 1.5mm</tradeName>
    <deviceName>Tenax Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEA15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:27.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEA141</udiDi>
    <basicUdiDi>B-D661TEA141</basicUdiDi>
    <tradeName>3 TENAX Drills 1.4mm</tradeName>
    <deviceName>Tenax Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEA14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:25.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEA131</udiDi>
    <basicUdiDi>B-D661TEA131</basicUdiDi>
    <tradeName>3 TENAX Drills 1.3mm</tradeName>
    <deviceName>Tenax Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEA13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:23.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEA121</udiDi>
    <basicUdiDi>B-D661TEA121</basicUdiDi>
    <tradeName>3 TENAX Drills 1.2mm</tradeName>
    <deviceName>Tenax Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEA12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:21.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661TEA111</udiDi>
    <basicUdiDi>B-D661TEA111</basicUdiDi>
    <tradeName>3 TENAX Drills 1.1mm</tradeName>
    <deviceName>Tenax Drills</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>MDD</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEA11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:20.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T151</udiDi>
    <basicUdiDi>B-D661T151</basicUdiDi>
    <tradeName>TMS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, Self-Shearing, 100 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:19.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T141</udiDi>
    <basicUdiDi>B-D661T141</basicUdiDi>
    <tradeName>TMS Refill, Regular Gold, Gold-Plated Stainless Steel, Self-Shearing, 50 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:17.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T1121</udiDi>
    <basicUdiDi>B-D661T1121</basicUdiDi>
    <tradeName>TMS Refill, Minuta Pink, Gold-Plated Stainless Steel, 50 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:15.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T121</udiDi>
    <basicUdiDi>B-D661T121</basicUdiDi>
    <tradeName>TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:14.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T111</udiDi>
    <basicUdiDi>B-D661T111</basicUdiDi>
    <tradeName>TMS Refill, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 50 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:12.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661T1111</udiDi>
    <basicUdiDi>B-D661T1111</basicUdiDi>
    <tradeName>TMS Complete-Kit, Minuta Pink, Gold-Plated Stainless Steel, 20 pcs</tradeName>
    <deviceName>TMS Pins</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>MDD</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:10.672Z</lastUpdated>
  </row>
</eudamedExport>