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    <deviceName>LOWER RIGHT 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>459-0110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:49.130Z</lastUpdated>
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    <basicUdiDi>B-00889989049251</basicUdiDi>
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    <deviceName>LOWER RIGHT 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>459-0109</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:46.724Z</lastUpdated>
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    <udiDi>00889989049244</udiDi>
    <basicUdiDi>B-00889989049244</basicUdiDi>
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    <deviceName>LOWER RIGHT 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>459-0108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:45.126Z</lastUpdated>
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    <udiDi>00889989049237</udiDi>
    <basicUdiDi>B-00889989049237</basicUdiDi>
    <tradeName>00889989049237</tradeName>
    <deviceName>LOWER RIGHT 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>459-0107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:44.326Z</lastUpdated>
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    <udiDi>00889989049220</udiDi>
    <basicUdiDi>B-00889989049220</basicUdiDi>
    <tradeName>00889989049220</tradeName>
    <deviceName>LOWER RIGHT 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>459-0106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:42.731Z</lastUpdated>
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    <udiDi>00889989049213</udiDi>
    <basicUdiDi>B-00889989049213</basicUdiDi>
    <tradeName>00889989049213</tradeName>
    <deviceName>LOWER RIGHT 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>459-0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:40.321Z</lastUpdated>
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    <udiDi>00889989049206</udiDi>
    <basicUdiDi>B-00889989049206</basicUdiDi>
    <tradeName>00889989049206</tradeName>
    <deviceName>LOWER RIGHT 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>459-0036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:38.725Z</lastUpdated>
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    <udiDi>00889989049190</udiDi>
    <basicUdiDi>B-00889989049190</basicUdiDi>
    <tradeName>00889989049190</tradeName>
    <deviceName>LOWER RIGHT 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>459-0035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:37.924Z</lastUpdated>
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    <udiDi>00889989049183</udiDi>
    <basicUdiDi>B-00889989049183</basicUdiDi>
    <tradeName>00889989049183</tradeName>
    <deviceName>LOWER RIGHT 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>459-0034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:36.330Z</lastUpdated>
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    <udiDi>00889989049176</udiDi>
    <basicUdiDi>B-00889989049176</basicUdiDi>
    <tradeName>00889989049176</tradeName>
    <deviceName>LOWER RIGHT 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>459-0033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:33.918Z</lastUpdated>
  </row>
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    <udiDi>00889989049169</udiDi>
    <basicUdiDi>B-00889989049169</basicUdiDi>
    <tradeName>00889989049169</tradeName>
    <deviceName>LOWER RIGHT 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>459-0032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:32.333Z</lastUpdated>
  </row>
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    <udiDi>00889989049152</udiDi>
    <basicUdiDi>B-00889989049152</basicUdiDi>
    <tradeName>00889989049152</tradeName>
    <deviceName>LOWER RIGHT 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>459-0031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:31.520Z</lastUpdated>
  </row>
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    <udiDi>00889989049145</udiDi>
    <basicUdiDi>B-00889989049145</basicUdiDi>
    <tradeName>00889989049145</tradeName>
    <deviceName>LOWER RIGHT 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>459-0030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:29.926Z</lastUpdated>
  </row>
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    <udiDi>00889989049138</udiDi>
    <basicUdiDi>B-00889989049138</basicUdiDi>
    <tradeName>00889989049138</tradeName>
    <deviceName>LOWER RIGHT 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>459-0029</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:27.518Z</lastUpdated>
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    <udiDi>00889989049121</udiDi>
    <basicUdiDi>B-00889989049121</basicUdiDi>
    <tradeName>00889989049121</tradeName>
    <deviceName>LOWER RIGHT 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>459-0028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:25.915Z</lastUpdated>
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    <udiDi>00889989049114</udiDi>
    <basicUdiDi>B-00889989049114</basicUdiDi>
    <tradeName>00889989049114</tradeName>
    <deviceName>LOWER RIGHT 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>459-0027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:25.147Z</lastUpdated>
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    <udiDi>00889989049107</udiDi>
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    <deviceName>LOWER RIGHT 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>459-0026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:23.531Z</lastUpdated>
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    <udiDi>00889989049077</udiDi>
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    <deviceName>LOWER RIGHT ULTIMA BAND SIZE 23</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>459-0023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:21.117Z</lastUpdated>
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    <deviceName>LOWER RIGHT 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>459-0025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:19.518Z</lastUpdated>
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    <deviceName>LOWER RIGHT ULTIMA BAND SIZE 24</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>459-0024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:24:18.713Z</lastUpdated>
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