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    <tradeName>U4&amp;5R TWIN DB/UL 22 ANDREWS OF/GV 2/-7</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 22 ANDREWS OF/GV 2/-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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:42.405Z</lastUpdated>
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    <udiDi>00889989050240</udiDi>
    <basicUdiDi>B-00889989050240</basicUdiDi>
    <tradeName>U5R TWIN DB/UL 22 ANDREWS T3 PA -2/-7/6</tradeName>
    <deviceName>U5R TWIN DB/UL 22 ANDREWS T3 PA -2/-7/6</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:41.609Z</lastUpdated>
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    <udiDi>00889989050264</udiDi>
    <basicUdiDi>B-00889989050264</basicUdiDi>
    <tradeName>U4R TWIN DB/UL 22 T2 PA 5/-7/4</tradeName>
    <deviceName>U4R TWIN DB/UL 22 T2 PA 5/-7/4</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:40.116Z</lastUpdated>
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    <udiDi>00889989050233</udiDi>
    <basicUdiDi>B-00889989050233</basicUdiDi>
    <tradeName>U5R TWIN DB/UL 22 T2 PA -1/-7/4</tradeName>
    <deviceName>U5R TWIN DB/UL 22 T2 PA -1/-7/4</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:26.351Z</lastUpdated>
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    <udiDi>00889989050226</udiDi>
    <basicUdiDi>B-00889989050226</basicUdiDi>
    <tradeName>U4&amp;5R TWIN DB/UL 22 BHK 2/-7</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 22 BHK 2/-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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:22.442Z</lastUpdated>
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    <udiDi>00889989050219</udiDi>
    <basicUdiDi>B-00889989050219</basicUdiDi>
    <tradeName>U4&amp;5R TWIN DB/UL 22 2/-7</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 22 2/-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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:20.758Z</lastUpdated>
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    <udiDi>00889989050202</udiDi>
    <basicUdiDi>B-00889989050202</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 18 ANDREWS T1 0/-7/2</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 18 ANDREWS T1 0/-7/2</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1079</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:19.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050196</udiDi>
    <basicUdiDi>B-00889989050196</basicUdiDi>
    <tradeName>U4&amp;5R TWIN DB/UL 18 ANDREWS T1 2/-7/2</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 18 ANDREWS T1 2/-7/2</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1072</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:19.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050189</udiDi>
    <basicUdiDi>B-00889989050189</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 18 ANDREWS DBHK 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 18 ANDREWS DBHK 2/-22</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1063</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:15.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050172</udiDi>
    <basicUdiDi>B-00889989050172</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 18 SPECIAL -5/-17</tradeName>
    <deviceName>L5R TWIN DB/UL 18 SPECIAL -5/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:14.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050165</udiDi>
    <basicUdiDi>B-00889989050165</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 18 ANDREWS 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 18 ANDREWS 2/-22</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1058</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:13.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050158</udiDi>
    <basicUdiDi>B-00889989050158</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 18 ANDREWS DBHK 2/-17</tradeName>
    <deviceName>L4R TWIN DB/UL 18 ANDREWS DBHK 2/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1051</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:12.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050141</udiDi>
    <basicUdiDi>B-00889989050141</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 18 ANDREWS 2/-17</tradeName>
    <deviceName>L4R TWIN DB/UL 18 ANDREWS 2/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1047</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:08.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050134</udiDi>
    <basicUdiDi>B-00889989050134</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 18 ANDREWS DBHK 2/-17</tradeName>
    <deviceName>L4L TWIN DB/UL 18 ANDREWS DBHK 2/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:08.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050127</udiDi>
    <basicUdiDi>B-00889989050127</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 18 ANDREWS 2/-17</tradeName>
    <deviceName>L4L TWIN DB/UL 18 ANDREWS 2/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:06.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050110</udiDi>
    <basicUdiDi>B-00889989050110</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 18 ANDREWS DBHK 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 18 ANDREWS DBHK 2/-22</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:05.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050103</udiDi>
    <basicUdiDi>B-00889989050103</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 18 SPECIAL -5/-17</tradeName>
    <deviceName>L5L TWIN DB/UL 18 SPECIAL -5/-17</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:01.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050097</udiDi>
    <basicUdiDi>B-00889989050097</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 18 ANDREWS 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 18 ANDREWS 2/-22</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:00.761Z</lastUpdated>
  </row>
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    <udiDi>00889989050080</udiDi>
    <basicUdiDi>B-00889989050080</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 18 BHK 2/-7</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 18 BHK 2/-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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:59.945Z</lastUpdated>
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    <udiDi>00889989050073</udiDi>
    <basicUdiDi>B-00889989050073</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 18 2/-7</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 18 2/-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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>463-1017</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:28:59.149Z</lastUpdated>
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