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    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 19</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 16</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:54.458Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 15</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:53.661Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 14</deviceName>
    <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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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:52.856Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 13</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:52.055Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA 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>458-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:48.053Z</lastUpdated>
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    <udiDi>00889989048377</udiDi>
    <basicUdiDi>B-00889989048377</basicUdiDi>
    <tradeName>00889989048377</tradeName>
    <deviceName>UPPER LEFT ULTIMA 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>458-0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:47.255Z</lastUpdated>
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    <udiDi>00889989048360</udiDi>
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    <deviceName>UPPER LEFT ULTIMA 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>458-0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:46.450Z</lastUpdated>
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    <udiDi>00889989048353</udiDi>
    <basicUdiDi>B-00889989048353</basicUdiDi>
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    <deviceName>UPPER LEFT ULTIMA 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>458-0009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:45.652Z</lastUpdated>
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    <udiDi>00889989048346</udiDi>
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    <deviceName>UPPER LEFT ULTIMA 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>458-0008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:41.647Z</lastUpdated>
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    <udiDi>00889989048339</udiDi>
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    <deviceName>UPPER LEFT ULTIMA 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>458-0007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:40.847Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 6</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:40.048Z</lastUpdated>
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    <deviceName>UPPER LEFT ULTIMA BAND SIZE 5</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>458-0005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:39.249Z</lastUpdated>
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    <deviceName>UPPER RIGHT ULTIMAX BAND SIZE 30</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>457-0130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:35.245Z</lastUpdated>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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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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    <emdnCode>Q010402</emdnCode>
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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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    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>457-0127</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:21:32.843Z</lastUpdated>
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