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    <tradeName>00889989086430</tradeName>
    <deviceName>L1R DAMON ULTIMA 22 -1/2/0 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>333-4100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:58:04.174Z</lastUpdated>
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    <udiDi>00889989086423</udiDi>
    <basicUdiDi>B-00889989086423</basicUdiDi>
    <tradeName>00889989086423</tradeName>
    <deviceName>L1L DAMON ULTIMA 22 RETROCLINE 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>333-3110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:58:01.768Z</lastUpdated>
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  <row>
    <udiDi>00889989086409</udiDi>
    <basicUdiDi>B-00889989086409</basicUdiDi>
    <tradeName>ORMESH PAD MOLAR U/L</tradeName>
    <deviceName>ORMESH PAD MOLAR U/L</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>300-0038</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:58:00.173Z</lastUpdated>
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  <row>
    <udiDi>00889989086386</udiDi>
    <basicUdiDi>B-00889989086386</basicUdiDi>
    <tradeName>ORMESH SLIM II MOLARPAD UPR/LWR</tradeName>
    <deviceName>ORMESH SLIM II MOLARPAD UPR/LWR</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>300-0189</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:59.369Z</lastUpdated>
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  <row>
    <udiDi>00889989086140</udiDi>
    <basicUdiDi>B-00889989086140</basicUdiDi>
    <tradeName>COPPER NITI 35 BAF 16 DIA UP LG PK10 W/STOPS</tradeName>
    <deviceName>COPPER NITI 35 BAF 16 DIA UP LG PK10 W/STOPS</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>299-0065</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:57.780Z</lastUpdated>
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  <row>
    <udiDi>00889989086133</udiDi>
    <basicUdiDi>B-00889989086133</basicUdiDi>
    <tradeName>COPPER NITI 35 BAF 19X25 UP LG PK10 W/STOPS</tradeName>
    <deviceName>COPPER NITI 35 BAF 19X25 UP LG PK10 W/STOPS</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>299-0035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:55.381Z</lastUpdated>
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  <row>
    <udiDi>00889989086126</udiDi>
    <basicUdiDi>B-00889989086126</basicUdiDi>
    <tradeName>COPPER NITI 35 BAF 17X25 UP LG PK10 W/STOPS</tradeName>
    <deviceName>COPPER NITI 35 BAF 17X25 UP LG PK10 W/STOPS</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>299-0033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:53.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989086119</udiDi>
    <basicUdiDi>B-00889989086119</basicUdiDi>
    <tradeName>COPPER NITI 35 BAF 16X22 UP LG PK10 W/STOPS</tradeName>
    <deviceName>COPPER NITI 35 BAF 16X22 UP LG PK10 W/STOPS</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>299-0032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:52.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989086027</udiDi>
    <basicUdiDi>B-00889989086027</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100</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>266-2104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:51.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989086010</udiDi>
    <basicUdiDi>B-00889989086010</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100</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>266-2103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:48.971Z</lastUpdated>
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  <row>
    <udiDi>00889989086003</udiDi>
    <basicUdiDi>B-00889989086003</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100</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>266-2102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:47.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085990</udiDi>
    <basicUdiDi>B-00889989085990</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100</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>266-2101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:46.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085983</udiDi>
    <basicUdiDi>B-00889989085983</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100</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>266-2100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:44.972Z</lastUpdated>
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  <row>
    <udiDi>00889989085976</udiDi>
    <basicUdiDi>B-00889989085976</basicUdiDi>
    <tradeName>35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100</tradeName>
    <deviceName>35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100</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>266-2001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:42.554Z</lastUpdated>
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  <row>
    <udiDi>00889989085914</udiDi>
    <basicUdiDi>B-00889989085914</basicUdiDi>
    <tradeName>U4&amp;5L DAMON Q2 WELDABLE 022 -11/+2/0 STD TQ</tradeName>
    <deviceName>U4&amp;5L DAMON Q2 WELDABLE 022 -11/+2/0 STD 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>161-8891</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:40.948Z</lastUpdated>
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    <udiDi>00889989085907</udiDi>
    <basicUdiDi>B-00889989085907</basicUdiDi>
    <tradeName>U4&amp;5R DAMON Q2 WELDABLE 022 -11/+2/0 STD TQ</tradeName>
    <deviceName>U4&amp;5R DAMON Q2 WELDABLE 022 -11/+2/0 STD 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>161-8890</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:40.147Z</lastUpdated>
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    <udiDi>00889989085969</udiDi>
    <basicUdiDi>B-00889989085969</basicUdiDi>
    <tradeName>INSIGNIA SL SINGLE PATIENT KIT MEXICALI</tradeName>
    <deviceName>INSIGNIA SL SINGLE PATIENT KIT MEXICALI</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728-9060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:38.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085891</udiDi>
    <basicUdiDi>B-00889989085891</basicUdiDi>
    <tradeName>L5L DAMON Q2 WELDABLE 022 -17/+4/0 STD TQ</tradeName>
    <deviceName>L5L DAMON Q2 WELDABLE 022 -17/+4/0 STD 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>161-8851</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:24.884Z</lastUpdated>
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  <row>
    <udiDi>00889989085884</udiDi>
    <basicUdiDi>B-00889989085884</basicUdiDi>
    <tradeName>L5R DAMON Q2 WELDABLE 022 -17/+4/0 STD TQ</tradeName>
    <deviceName>L5R DAMON Q2 WELDABLE 022 -17/+4/0 STD 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>161-8850</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:20.887Z</lastUpdated>
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    <udiDi>00889989085877</udiDi>
    <basicUdiDi>B-00889989085877</basicUdiDi>
    <tradeName>L4L DAMON Q2 WELDABLE 022 -5/+4/0 HI TQ</tradeName>
    <deviceName>L4L DAMON Q2 WELDABLE 022 -5/+4/0 HI 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>161-8843</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:20.084Z</lastUpdated>
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