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    <deviceName>U4&amp;5R TWIN DB/UL 22 ROTH HK 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>464-1084</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:58.496Z</lastUpdated>
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    <udiDi>00889989050653</udiDi>
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    <tradeName>U4&amp;5R TWIN DB/UL 22 ROTH 0/-7/2</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 22 ROTH 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>464-1083</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:57.695Z</lastUpdated>
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    <udiDi>00889989050646</udiDi>
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    <tradeName>U4&amp;5R TWIN DB/UL 22 ANDREWS T1 0/-7/2</tradeName>
    <deviceName>U4&amp;5R TWIN DB/UL 22 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>464-1081</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:56.893Z</lastUpdated>
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    <udiDi>00889989050639</udiDi>
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    <tradeName>L5R TWIN DB/UL 22 ANDREWS DBHK OF/GV 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ANDREWS DBHK OF/GV 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>464-1079</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:56.088Z</lastUpdated>
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    <udiDi>00889989050622</udiDi>
    <basicUdiDi>B-00889989050622</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS OF/GV 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ANDREWS OF/GV 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>464-1078</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:52.090Z</lastUpdated>
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    <udiDi>00889989050615</udiDi>
    <basicUdiDi>B-00889989050615</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS T3 PA -2/-22/6</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ANDREWS T3 PA -2/-22/6</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>464-1077</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:51.287Z</lastUpdated>
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    <udiDi>00889989050608</udiDi>
    <basicUdiDi>B-00889989050608</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS T2 PA -1/-22/4</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ANDREWS T2 PA -1/-22/4</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>464-1076</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:50.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050592</udiDi>
    <basicUdiDi>B-00889989050592</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS T1 PA 0/-22/2</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ANDREWS T1 PA 0/-22/2</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>464-1075</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:49.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050561</udiDi>
    <basicUdiDi>B-00889989050561</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ROTH N/HK -1/-22/4</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ROTH N/HK -1/-22/4</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>464-1071</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:45.686Z</lastUpdated>
  </row>
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    <udiDi>00889989050585</udiDi>
    <basicUdiDi>B-00889989050585</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ROTH BHK -1/-22/4</tradeName>
    <deviceName>L5R TWIN DB/UL 22 ROTH BHK -1/-22/4</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>464-1074</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:44.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050578</udiDi>
    <basicUdiDi>B-00889989050578</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS DBHK 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 22 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>464-1073</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:44.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050554</udiDi>
    <basicUdiDi>B-00889989050554</basicUdiDi>
    <tradeName>L5R TWIN DB/UL 22 ANDREWS 2/-22</tradeName>
    <deviceName>L5R TWIN DB/UL 22 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>464-1068</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:43.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050547</udiDi>
    <basicUdiDi>B-00889989050547</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ANDRWS T3 PA -2/-22/6</tradeName>
    <deviceName>L4R TWIN DB/UL 22 ANDRWS T3 PA -2/-22/6</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>464-1064</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:27.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050530</udiDi>
    <basicUdiDi>B-00889989050530</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ANDREWS T2 PA 5/-17/4</tradeName>
    <deviceName>L4R TWIN DB/UL 22 ANDREWS T2 PA 5/-17/4</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>464-1063</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:26.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050523</udiDi>
    <basicUdiDi>B-00889989050523</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ROTH DBHK -1/-17/4</tradeName>
    <deviceName>L4R TWIN DB/UL 22 ROTH DBHK -1/-17/4</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>464-1061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:24.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050516</udiDi>
    <basicUdiDi>B-00889989050516</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ANDREWS DBHK 2/-17</tradeName>
    <deviceName>L4R TWIN DB/UL 22 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>464-1059</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:22.425Z</lastUpdated>
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    <udiDi>00889989050509</udiDi>
    <basicUdiDi>B-00889989050509</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ROTH HK -1/-17/4</tradeName>
    <deviceName>L4R TWIN DB/UL 22 ROTH HK -1/-17/4</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>464-1058</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:20.823Z</lastUpdated>
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    <udiDi>00889989050493</udiDi>
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    <tradeName>L4R TWIN DB/UL 22 ROTH NHK -1/-17/4</tradeName>
    <deviceName>L4R TWIN DB/UL 22 ROTH NHK -1/-17/4</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>464-1057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:20.034Z</lastUpdated>
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    <udiDi>00889989050486</udiDi>
    <basicUdiDi>B-00889989050486</basicUdiDi>
    <tradeName>L4R TWIN DB/UL 22 ANDREWS 2/-17</tradeName>
    <deviceName>L4R TWIN DB/UL 22 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>464-1054</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:18.422Z</lastUpdated>
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    <deviceName>L4L TWIN DB/UL 22 ANDREWS T3 PA -2/-22/6</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>464-1050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:16.029Z</lastUpdated>
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