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    <deviceName>MINI MESH GOFF UPBIC -7T 0A 022</deviceName>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00889989086997</udiDi>
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    <tradeName>DAMON ULTIMA ARCHWIRE TMA 10PK 18X275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE TMA 10PK 18X275</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:59.551Z</lastUpdated>
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    <udiDi>00889989086980</udiDi>
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    <tradeName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - 140 x 275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - 140 x 275</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>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:57.148Z</lastUpdated>
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    <tradeName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - 180 x 275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - 180 x 275</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>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:55.552Z</lastUpdated>
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    <tradeName>DAMON ULTIMA ARCHWIRE SST 10PK 18X275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE SST 10PK 18X275</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-1272</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:54.756Z</lastUpdated>
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    <udiDi>00889989086959</udiDi>
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    <tradeName>DAMON ULTIMA ARCHWIRE SST 10PK 16X275</tradeName>
    <deviceName>DAMON ULTIMA ARCHWIRE SST 10PK 16X275</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>227-1267</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:53.150Z</lastUpdated>
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    <udiDi>00889989086942</udiDi>
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    <tradeName>00889989086942</tradeName>
    <deviceName>U4,5L DAMON ULTIMA 22 PROCLINE 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>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333-2420</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:50.752Z</lastUpdated>
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    <deviceName>U4,5R DAMON ULTIMA 22 PROCLINE 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>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:49.142Z</lastUpdated>
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    <udiDi>00889989086928</udiDi>
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    <tradeName>00889989086928</tradeName>
    <deviceName>U4 and 5L DAMON ULTIMA 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>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333-2400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:48.341Z</lastUpdated>
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    <deviceName>U4 and 5R DAMON ULTIMA 22 -4/2/0 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>333-1400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:46.737Z</lastUpdated>
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    <deviceName>U4,5L DAMON ULTIMA 22 RETROCLINE TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333-2410</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:44.350Z</lastUpdated>
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    <deviceName>U3L DAMON ULTIMA 22 PROCLINE TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:42.738Z</lastUpdated>
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    <deviceName>U3R DAMON ULTIMA 22 PROCLINE TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:59:41.946Z</lastUpdated>
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    <deviceName>U4,5R DAMON ULTIMA 22 RETROCLINE TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <deviceName>U3R DAMON ULTIMA 22 -2/5/0 NEUTRAL TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>U3L DAMON ULTIMA 22 RETROCLINE TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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