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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <deviceName>L5L DAMON ULTIMA G-OFF 22 -17/4/0 NEUTRAL TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>L4L DAMON ULTIMA G-OFF 22 -12/4/0 NEUTRAL TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <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>333-3406</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:44.418Z</lastUpdated>
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    <deviceName>U4 AND 5R DAMON ULTIMA G-OFF 22 -4/2/0 NEUTRAL TQ</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>
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    <tradeName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0210 x .0275</tradeName>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:27.561Z</lastUpdated>
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    <tradeName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0200 x .0275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0200 x .0275</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-1165</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:26.761Z</lastUpdated>
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    <tradeName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0190 x .0275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0190 x .0275</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-1164</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:25.164Z</lastUpdated>
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    <udiDi>00889989088243</udiDi>
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    <tradeName>DAMON ULTIMA ARCHWIRE TMA 10PK - .0200 x .0275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE TMA 10PK - .0200 x .0275</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-1122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:22.774Z</lastUpdated>
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    <tradeName>DAMON ULTIMA ARCHWIRE TMA 10PK - .0190 x .0275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE TMA 10PK - .0190 x .0275</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-1116</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:21.195Z</lastUpdated>
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    <deviceName>7-7 U/L DAMON ULTIMA SINGLE PATIENT KIT U3-3 PROCLINE , L2-2 RETROCLINE SNAPLINK TITANIUM</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>740-1446</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:20.381Z</lastUpdated>
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    <deviceName>5-5 U/L DAMON ULTIMA SINGLE PATIENT KIT U3-3 PROCLINE , L2-2 RETROCLINE</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <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>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:18.757Z</lastUpdated>
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    <deviceName>7-7 U/L DAMON ULTIMA SINGLE PATIENT KIT U2-2 RETROCLINE, SNAPLINK, AND TI TUBES</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:16.359Z</lastUpdated>
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    <deviceName>5-5 U/L DAMON ULTIMA SINGLE PATIENT KIT U2-2 RETROCLINE</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:00:14.759Z</lastUpdated>
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    <deviceName>7-7 U/L DAMON ULTIMA SINGLE PATIENT KIT NEUTRAL TORQUE, SNAPLINK, AND TI TUBES</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <deviceName>5-5 U/L DAMON ULTIMA SINGLE PATIENT KIT NEUTRAL TORQUE</deviceName>
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    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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