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    <deviceName>L5L MTWNVS DB/UL 22 RTH NHK -1/-22/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <lastUpdated>2026-07-05T12:33:00.274Z</lastUpdated>
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    <deviceName>L5R MTWNVS DB/UL 22 RTH NHK -1/-22/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <deviceName>L4R MTWNVS DB/UL 22 RTH 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>493-0610</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:57.870Z</lastUpdated>
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    <udiDi>00889989052961</udiDi>
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    <tradeName>U4&amp;5L MINITWIN VS DB/UL 22 ROTH 0/-7/2</tradeName>
    <deviceName>U4&amp;5L MINITWIN VS 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>493-0511</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:53.872Z</lastUpdated>
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    <udiDi>00889989052954</udiDi>
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    <tradeName>U4&amp;5R MINITWIN VS DB/UL 22 ROTH 0/-7/2</tradeName>
    <deviceName>U4&amp;5R MINITWIN VS 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>493-0510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:53.069Z</lastUpdated>
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    <udiDi>00889989052947</udiDi>
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    <tradeName>L5L MTWNVS DB/UL 18 RTH DHK -1/-22/4</tradeName>
    <deviceName>L5L MTWNVS DB/UL 18 RTH DHK -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>492-1711</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:52.268Z</lastUpdated>
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    <tradeName>L5R MTWNVS DB/UL 18 RTH DHK -1/-22/4</tradeName>
    <deviceName>L5R MTWNVS DB/UL 18 RTH DHK -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>492-1710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:51.469Z</lastUpdated>
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    <udiDi>00889989052909</udiDi>
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    <tradeName>U4&amp;5L MINITWIN VS DB/UL 18 ROTH DBHK 0/-7/2</tradeName>
    <deviceName>U4&amp;5L MINITWIN VS DB/UL 18 ROTH DBHK 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>492-1511</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:47.473Z</lastUpdated>
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    <udiDi>00889989052923</udiDi>
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    <tradeName>L4L MTWNVS DB/UL 18 RTH DBK -1/-17/4</tradeName>
    <deviceName>L4L MTWNVS DB/UL 18 RTH DBK -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>492-1611</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:46.678Z</lastUpdated>
  </row>
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    <udiDi>00889989052916</udiDi>
    <basicUdiDi>B-00889989052916</basicUdiDi>
    <tradeName>L4R MTWNVS DB/UL 18 RTH DHK -1/-17/4</tradeName>
    <deviceName>L4R MTWNVS DB/UL 18 RTH DHK -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>492-1610</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:45.868Z</lastUpdated>
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    <udiDi>00889989052893</udiDi>
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    <tradeName>U4&amp;5R MINITWIN VS DB/UL 18 ROTH DBHK 0/-7/2</tradeName>
    <deviceName>U4&amp;5R MINITWIN VS DB/UL 18 ROTH DBHK 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>492-1510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:45.061Z</lastUpdated>
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    <udiDi>00889989052886</udiDi>
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    <tradeName>L5L MTWNVS DB/UL 18 RTH NHK -1/-22/4</tradeName>
    <deviceName>L5L MTWNVS DB/UL 18 RTH NHK -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>492-0711</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:29.003Z</lastUpdated>
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    <udiDi>00889989052879</udiDi>
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    <tradeName>L5R MTWNVS DB/UL 18 RTH NHK -1/-22/4</tradeName>
    <deviceName>L5R MTWNVS DB/UL 18 RTH NHK -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>492-0710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:28.200Z</lastUpdated>
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    <deviceName>L4L MTWNVS DB/UL 18 RTH 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>492-0611</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:26.594Z</lastUpdated>
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    <deviceName>L4R MTWNVS DB/UL 18 RTH NHK -1/-17/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnCode>Q010403</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>492-0610</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:24.198Z</lastUpdated>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>492-0511</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:22.612Z</lastUpdated>
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    <deviceName>U4&amp;5R MINITWIN VS DB/UL 18 ROTH 0/-7/2</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>492-0510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:21.810Z</lastUpdated>
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    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:32:17.791Z</lastUpdated>
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