<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D7461AH501</udiDi>
    <basicUdiDi>++D746ESSIXACEEA</basicUdiDi>
    <tradeName>Essix ACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1AH50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL35C1201</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL35C120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL35C1251</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL35C125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL35S1251</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL35S125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL35S51</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL35S5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL40C1201</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL40C120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL40C1251</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL40C125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL40S1251</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL40S125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461APL40S51</udiDi>
    <basicUdiDi>++D746ESSIXPLUSXW</basicUdiDi>
    <tradeName>Essix PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1APL40S5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C1201</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C120501</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C120-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C1251</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C125501</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C125-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C4781</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C478</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C5001</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461C500501</udiDi>
    <basicUdiDi>++D746ESSIXC7E</basicUdiDi>
    <tradeName>Essix C+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1C500-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746400341</udiDi>
    <basicUdiDi>++D746SFSTRIPDG</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>D74640034LS1</udiDi>
    <basicUdiDi>++D746SFSTRIPDG</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40034-LS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D74640034RS1</udiDi>
    <basicUdiDi>++D746SFSTRIPDG</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40034-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D74640035BL1</udiDi>
    <basicUdiDi>++D746SFSTRIPDG</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40035-BL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.078Z</lastUpdated>
  </row>
</eudamedExport>