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    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 12</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:21.611Z</lastUpdated>
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    <udiDi>00889989049855</udiDi>
    <basicUdiDi>B-00889989049855</basicUdiDi>
    <tradeName>00889989049855</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 11</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:19.929Z</lastUpdated>
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    <udiDi>00889989049848</udiDi>
    <basicUdiDi>B-00889989049848</basicUdiDi>
    <tradeName>00889989049848</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 10</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:19.121Z</lastUpdated>
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    <udiDi>00889989049831</udiDi>
    <basicUdiDi>B-00889989049831</basicUdiDi>
    <tradeName>00889989049831</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 9</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0109</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:18.326Z</lastUpdated>
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    <udiDi>00889989049824</udiDi>
    <basicUdiDi>B-00889989049824</basicUdiDi>
    <tradeName>00889989049824</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 8</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:14.312Z</lastUpdated>
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    <udiDi>00889989049817</udiDi>
    <basicUdiDi>B-00889989049817</basicUdiDi>
    <tradeName>00889989049817</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 7</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:13.515Z</lastUpdated>
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    <udiDi>00889989049800</udiDi>
    <basicUdiDi>B-00889989049800</basicUdiDi>
    <tradeName>00889989049800</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 6</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:12.714Z</lastUpdated>
  </row>
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    <udiDi>00889989049794</udiDi>
    <basicUdiDi>B-00889989049794</basicUdiDi>
    <tradeName>00889989049794</tradeName>
    <deviceName>LOWER LEFT ULTIMAX BAND SIZE 5</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:11.908Z</lastUpdated>
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  <row>
    <udiDi>00889989049787</udiDi>
    <basicUdiDi>B-00889989049787</basicUdiDi>
    <tradeName>00889989049787</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 36</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:07.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049770</udiDi>
    <basicUdiDi>B-00889989049770</basicUdiDi>
    <tradeName>00889989049770</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 35</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:07.105Z</lastUpdated>
  </row>
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    <udiDi>00889989049763</udiDi>
    <basicUdiDi>B-00889989049763</basicUdiDi>
    <tradeName>00889989049763</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 34</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:06.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049756</udiDi>
    <basicUdiDi>B-00889989049756</basicUdiDi>
    <tradeName>00889989049756</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 33</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:04.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049749</udiDi>
    <basicUdiDi>B-00889989049749</basicUdiDi>
    <tradeName>00889989049749</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 32</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:30.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049732</udiDi>
    <basicUdiDi>B-00889989049732</basicUdiDi>
    <tradeName>00889989049732</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 31</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:29.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049725</udiDi>
    <basicUdiDi>B-00889989049725</basicUdiDi>
    <tradeName>00889989049725</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 30</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:27.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989049718</udiDi>
    <basicUdiDi>B-00889989049718</basicUdiDi>
    <tradeName>00889989049718</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 29</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0029</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:26.865Z</lastUpdated>
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  <row>
    <udiDi>00889989049701</udiDi>
    <basicUdiDi>B-00889989049701</basicUdiDi>
    <tradeName>00889989049701</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 28</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:25.279Z</lastUpdated>
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    <udiDi>00889989049671</udiDi>
    <basicUdiDi>B-00889989049671</basicUdiDi>
    <tradeName>00889989049671</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 25</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:22.870Z</lastUpdated>
  </row>
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    <udiDi>00889989049695</udiDi>
    <basicUdiDi>B-00889989049695</basicUdiDi>
    <tradeName>00889989049695</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 27</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:21.273Z</lastUpdated>
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    <udiDi>00889989049688</udiDi>
    <basicUdiDi>B-00889989049688</basicUdiDi>
    <tradeName>00889989049688</tradeName>
    <deviceName>LOWER LEFT ULTIMA BAND SIZE 26</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>460-0026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:26:20.464Z</lastUpdated>
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