<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00190746034923</udiDi>
    <basicUdiDi>01907460000197EG</basicUdiDi>
    <tradeName>Debond Wafer</tradeName>
    <deviceName>Debond Wafer</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>861-015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:52:32.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746008115</udiDi>
    <basicUdiDi>01907460000199EL</basicUdiDi>
    <tradeName>Impressa/Chrome</tradeName>
    <deviceName>Impressa/Chrome</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>861-130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:52:22.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746164767</udiDi>
    <basicUdiDi>01907460000174E4</basicUdiDi>
    <tradeName>PowerBar</tradeName>
    <deviceName>PowerBar</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:55.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746162350</udiDi>
    <basicUdiDi>01907460000181DZ</basicUdiDi>
    <tradeName>Band Pusher</tradeName>
    <deviceName>Band Pusher</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:54.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746144257</udiDi>
    <basicUdiDi>01907460000146DX</basicUdiDi>
    <tradeName>Utility Traction Hook</tradeName>
    <deviceName>Utility Traction Hook</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-030754</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:47.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133602</udiDi>
    <basicUdiDi>01907460000116DN</basicUdiDi>
    <tradeName>Bondable Elastic Lug</tradeName>
    <deviceName>Bondable Elastic Lug</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593-190</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:41.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133558</udiDi>
    <basicUdiDi>01907460000117DQ</basicUdiDi>
    <tradeName>Bondable Eyelet</tradeName>
    <deviceName>Bondable Eyelet</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>292-186</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:39.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133534</udiDi>
    <basicUdiDi>01907460000145DV</basicUdiDi>
    <tradeName>Tongue Director</tradeName>
    <deviceName>Tongue Director</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>292-184</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:35.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133459</udiDi>
    <basicUdiDi>01907460000176E8</basicUdiDi>
    <tradeName>Quad Helix</tradeName>
    <deviceName>Quad Helix</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-551</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:35.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133305</udiDi>
    <basicUdiDi>01907460000173E2</basicUdiDi>
    <tradeName>Palatal Arch</tradeName>
    <deviceName>Palatal Arch</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-521</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:34.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133244</udiDi>
    <basicUdiDi>01907460000109DR</basicUdiDi>
    <tradeName>Weldable Elastic Lug</tradeName>
    <deviceName>Weldable Elastic Lug</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-190PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:33.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133176</udiDi>
    <basicUdiDi>01907460000111DC</basicUdiDi>
    <tradeName>Weldable Gull Wing Cleats</tradeName>
    <deviceName>Weldable Gull Wing Cleats</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-165PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:29.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133169</udiDi>
    <basicUdiDi>01907460000107DM</basicUdiDi>
    <tradeName>Seating Lug</tradeName>
    <deviceName>Seating Lug</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:28.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746133152</udiDi>
    <basicUdiDi>01907460000110DA</basicUdiDi>
    <tradeName>Weldable Eyelet</tradeName>
    <deviceName>Weldable Eyelet</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-150PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:28.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746132971</udiDi>
    <basicUdiDi>01907460000101D9</basicUdiDi>
    <tradeName>Lingual Sheath</tradeName>
    <deviceName>Lingual Sheath</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-143L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:26.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746132964</udiDi>
    <basicUdiDi>01907460000119DU</basicUdiDi>
    <tradeName>Bondable Cleat</tradeName>
    <deviceName>Bondable Cleat</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>593-166</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:10.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746132957</udiDi>
    <basicUdiDi>01907460000118DS</basicUdiDi>
    <tradeName>Bondable Gull Wing Cleat</tradeName>
    <deviceName>Bondable Gull Wing Cleat</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593-165</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:09.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746125577</udiDi>
    <basicUdiDi>01907460000112DE</basicUdiDi>
    <tradeName>Weldable Hook</tradeName>
    <deviceName>Weldable Hook</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-182</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:08.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746114748</udiDi>
    <basicUdiDi>01907460000113DG</basicUdiDi>
    <tradeName>Weldable Cleat</tradeName>
    <deviceName>Weldable Cleat</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>852-168</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:45:02.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746076305</udiDi>
    <basicUdiDi>01907460000172DY</basicUdiDi>
    <tradeName>Miniscope Telescoping Herbst</tradeName>
    <deviceName>Miniscope Telescoping Herbst</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-918L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:54.904Z</lastUpdated>
  </row>
</eudamedExport>