<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.755Z</lastUpdated>
  </row>
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S2130</udiDi>
    <basicUdiDi>B-D661S2130</basicUdiDi>
    <tradeName>PerFect TCS Dispersive Electrode</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6000CE1</udiDi>
    <basicUdiDi>B-D661S6000CE1</basicUdiDi>
    <tradeName>PerFect TCS Sterilizable Electrodes and Cord Assembly, 8 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6000CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6008CE0</udiDi>
    <basicUdiDi>B-D661S6008CE0</basicUdiDi>
    <tradeName>PerFect TCS Cord Assembly</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6008CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6010A1</udiDi>
    <basicUdiDi>B-D661S6010A1</basicUdiDi>
    <tradeName>PerFect TCS Sterilizable Electrode Sheaths, 8 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6010A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6011A1</udiDi>
    <basicUdiDi>B-D661S6011A1</basicUdiDi>
    <tradeName>PerFect TCS 45º Coag Small Ball Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6011A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6012A1</udiDi>
    <basicUdiDi>B-D661S6012A1</basicUdiDi>
    <tradeName>PerFect TCS 45º Straight Knife Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6012A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6013A1</udiDi>
    <basicUdiDi>B-D661S6013A1</basicUdiDi>
    <tradeName>PerFect TCS 45º Tapered Knife Electrode Sheaths, 2pcs</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6013A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6014A1</udiDi>
    <basicUdiDi>B-D661S6014A1</basicUdiDi>
    <tradeName>PerFect TCS Straight Round Loop Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6014A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6015A1</udiDi>
    <basicUdiDi>B-D661S6015A1</basicUdiDi>
    <tradeName>PerFect TCS 45º Long Loop Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6015A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6016A1</udiDi>
    <basicUdiDi>B-D661S6016A1</basicUdiDi>
    <tradeName>PerFect TCS Straight Long Loop Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6016A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6017A1</udiDi>
    <basicUdiDi>B-D661S6017A1</basicUdiDi>
    <tradeName>PerFect TCS 45º Diamond Loop Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6017A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S6018A1</udiDi>
    <basicUdiDi>B-D661S6018A1</basicUdiDi>
    <tradeName>PerFect TCS 90º AP 1 1/2 Electrode Sheaths, 2 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S6018A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661S70010</udiDi>
    <basicUdiDi>B-D661S70010</basicUdiDi>
    <tradeName>PerFect TCS Handpiece 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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S7001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:46.382Z</lastUpdated>
  </row>
</eudamedExport>