<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D746110811</udiDi>
    <basicUdiDi>++D746ESSIXA7A</basicUdiDi>
    <tradeName>Essix A+</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>11081</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746131201</udiDi>
    <basicUdiDi>++D746ESSIXA7A</basicUdiDi>
    <tradeName>Essix A+</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>13120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746135001</udiDi>
    <basicUdiDi>++D746ESSIXA7A</basicUdiDi>
    <tradeName>Essix A+</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>13500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A3201</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>1A320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A320501</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>1A320-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A3251</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>1A325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A325501</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>1A325-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A3471</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>1A347</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A3501</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>1A350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A350501</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>1A350-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A4201</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>1A420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A420501</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>1A420-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A4251</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>1A425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A425501</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>1A425-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A4501</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>1A450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A450501</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>1A450-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461A4781</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>1A478</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461AH201</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>1AH20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461AH251</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>1AH25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7461AH3471</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>1AH347</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:31.294Z</lastUpdated>
  </row>
</eudamedExport>