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    <tradeName>Mesial Jet</tradeName>
    <deviceName>Mesial Jet</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-522</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:51.040Z</lastUpdated>
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    <udiDi>00190746075568</udiDi>
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    <tradeName>Spring Jet</tradeName>
    <deviceName>Spring Jet</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-520</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:50.202Z</lastUpdated>
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    <udiDi>00190746075537</udiDi>
    <basicUdiDi>01907460000180DX</basicUdiDi>
    <tradeName>Uprighter Jet</tradeName>
    <deviceName>Uprighter Jet</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-513</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:49.373Z</lastUpdated>
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    <udiDi>00190746074714</udiDi>
    <basicUdiDi>01907460000120DD</basicUdiDi>
    <tradeName>Bondable Retainer</tradeName>
    <deviceName>Bondable Retainer</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-280</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:48.564Z</lastUpdated>
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  <row>
    <udiDi>00190746074493</udiDi>
    <basicUdiDi>01907460000123DK</basicUdiDi>
    <tradeName>Diastema</tradeName>
    <deviceName>Diastema</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>855-250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:44.459Z</lastUpdated>
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  <row>
    <udiDi>00190746074288</udiDi>
    <basicUdiDi>01907460000115DL</basicUdiDi>
    <tradeName>Bite Blocks</tradeName>
    <deviceName>Bite Blocks</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>855-200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:43.620Z</lastUpdated>
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  <row>
    <udiDi>00190746073328</udiDi>
    <basicUdiDi>01907460000170DU</basicUdiDi>
    <tradeName>Lip Bumper</tradeName>
    <deviceName>Lip Bumper</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>852-699</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:42.798Z</lastUpdated>
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  <row>
    <udiDi>00190746073175</udiDi>
    <basicUdiDi>01907460000165E3</basicUdiDi>
    <tradeName>Gentle Jumper</tradeName>
    <deviceName>Gentle Jumper</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>852-670</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:41.961Z</lastUpdated>
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  <row>
    <udiDi>00190746068201</udiDi>
    <basicUdiDi>01907460000166E5</basicUdiDi>
    <tradeName>Hanks Telescoping Herbst</tradeName>
    <deviceName>Hanks 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>855-727PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:38.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746067884</udiDi>
    <basicUdiDi>01907460000169EB</basicUdiDi>
    <tradeName>Jones Jig</tradeName>
    <deviceName>Jones Jig</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>855-404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:37.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746067662</udiDi>
    <basicUdiDi>01907460000168E9</basicUdiDi>
    <tradeName>Jasper Jumper</tradeName>
    <deviceName>Jasper Jumper</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>852-906</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:36.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746067600</udiDi>
    <basicUdiDi>01907460000178EC</basicUdiDi>
    <tradeName>Rapid Molar Intruder</tradeName>
    <deviceName>Rapid Molar Intruder</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>852-201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:35.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746067549</udiDi>
    <basicUdiDi>01907460000175E6</basicUdiDi>
    <tradeName>PowerScope</tradeName>
    <deviceName>PowerScope</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>852-016539</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:32.477Z</lastUpdated>
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  <row>
    <udiDi>00190746067501</udiDi>
    <basicUdiDi>01907460000177EA</basicUdiDi>
    <tradeName>Quick Fix</tradeName>
    <deviceName>Quick Fix</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>851-638CL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:32.420Z</lastUpdated>
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  <row>
    <udiDi>00190746059650</udiDi>
    <basicUdiDi>01907460000167E7</basicUdiDi>
    <tradeName>Herbst Appliance</tradeName>
    <deviceName>Herbst Appliance</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>852-027452</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:44:00.872Z</lastUpdated>
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    <udiDi>00190746057953</udiDi>
    <basicUdiDi>01907460000182E3</basicUdiDi>
    <tradeName>Bite Stick</tradeName>
    <deviceName>Bite Stick</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>001-036731</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:46.513Z</lastUpdated>
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    <udiDi>00190746021411</udiDi>
    <basicUdiDi>01907460000164DZ</basicUdiDi>
    <tradeName>Distal Jet</tradeName>
    <deviceName>Distal Jet</deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855-509</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:36.292Z</lastUpdated>
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    <udiDi>00190707108137</udiDi>
    <basicUdiDi>0190730OTElastAttachersB6</basicUdiDi>
    <tradeName>Elastic Attachers</tradeName>
    <deviceName>Dental Hand Instrument</deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
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    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:25.702Z</lastUpdated>
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    <udiDi>00190707083847</udiDi>
    <basicUdiDi>0190707O2ReliefWaxVL</basicUdiDi>
    <tradeName>Orthodontic Relief Wax</tradeName>
    <deviceName>Intraoral Dental Wax</deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
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    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:24.145Z</lastUpdated>
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    <udiDi>00190707143008</udiDi>
    <basicUdiDi>0190730OTReliefWaxPC</basicUdiDi>
    <tradeName>ORTHO PERFORMANCE Relief Wax</tradeName>
    <deviceName>Intraoral Dental Wax</deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:22.048Z</lastUpdated>
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