<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D746AC150GMDS1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC150GMDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746AC150PBGDS1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC150PBGDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746AC150PGDS1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC150PGDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746AC150WDS1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC150WDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746AC150YPINDS1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC150YPINDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACGM1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-GM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACPBG1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-PBG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACPG1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-PG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACW1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:30.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACWR1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-W-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ACYPIN1</udiDi>
    <basicUdiDi>++D746ALIGNERSEATER5E</basicUdiDi>
    <tradeName>Chewies</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>AC-YPIN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ART011</udiDi>
    <basicUdiDi>++D746ARTTL</basicUdiDi>
    <tradeName>N/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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ART01R1</udiDi>
    <basicUdiDi>++D746ARTTL</basicUdiDi>
    <tradeName>N/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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART01-R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746EB251</udiDi>
    <basicUdiDi>++D746WAFER84</basicUdiDi>
    <tradeName>Therapy Wafer</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>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746EB25G1</udiDi>
    <basicUdiDi>++D746WAFER84</basicUdiDi>
    <tradeName>Therapy Wafer</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>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-25G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746EB25M1</udiDi>
    <basicUdiDi>++D746WAFER84</basicUdiDi>
    <tradeName>Therapy Wafer</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>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-25M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746EB25PBG1</udiDi>
    <basicUdiDi>++D746WAFER84</basicUdiDi>
    <tradeName>Therapy Wafer</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>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-25PBG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746RB2361</udiDi>
    <basicUdiDi>++D746RBBV</basicUdiDi>
    <tradeName>D746RB2361</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB2-36</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746RB236CASE1</udiDi>
    <basicUdiDi>++D746RBBV</basicUdiDi>
    <tradeName>D746RB236CASE1</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB2-36-CASE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746RB2921</udiDi>
    <basicUdiDi>++D746RBBV</basicUdiDi>
    <tradeName>D746RB2921</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB2-92</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:50:27.374Z</lastUpdated>
  </row>
</eudamedExport>