<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D746ORX000061</udiDi>
    <basicUdiDi>++D746SSDOCTORKITTA</basicUdiDi>
    <tradeName>SureSmile</tradeName>
    <deviceName>SureSmile Aligner Starter Kit (Doctor Kit)</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000000828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORX00006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:12.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ORX000051</udiDi>
    <basicUdiDi>++D746SSpatientkitKL</basicUdiDi>
    <tradeName>SureSmile</tradeName>
    <deviceName>SureSmile Aligner Patient Kit</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000000828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D050199</emdnCode>
    <emdnDescription>ASSOCIATED PERACETIC ACID FOR THE DISINFECTION OF MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORX00005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:10.614Z</lastUpdated>
  </row>
</eudamedExport>