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    <tradeName>CLASP RETAINER BALL .028 PK 10 JHI CPS006-210</tradeName>
    <deviceName>CLASP RETAINER BALL .028 PK 10 JHI CPS006-210</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>242-0028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:35.558Z</lastUpdated>
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  <row>
    <udiDi>00889989074611</udiDi>
    <basicUdiDi>B-00889989074611</basicUdiDi>
    <tradeName>LINGUAL BALL HOOK SHORT        1-1010</tradeName>
    <deviceName>LINGUAL BALL HOOK SHORT        1-1010</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>242-0005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:34.753Z</lastUpdated>
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  <row>
    <udiDi>00889989074604</udiDi>
    <basicUdiDi>B-00889989074604</basicUdiDi>
    <tradeName>LABIAL HEMISPHERICAL HOOK      1-1010</tradeName>
    <deviceName>LABIAL HEMISPHERICAL HOOK      1-1010</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>242-0004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:33.959Z</lastUpdated>
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  <row>
    <udiDi>00889989074451</udiDi>
    <basicUdiDi>B-00889989074451</basicUdiDi>
    <tradeName>FORESTADENT SMALL CLEAT</tradeName>
    <deviceName>FORESTADENT SMALL CLEAT</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>088-4065</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:33.142Z</lastUpdated>
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    <udiDi>00889989062069</udiDi>
    <basicUdiDi>B-00889989062069</basicUdiDi>
    <tradeName>DC2 U3-3 Std Tq, DC U4-5 Std Tq, DC L3-3 Std Tq, DQ L4-5 Std Tq; Peerless Tubes on the 6's, Accent Mini &amp; Ortho Accent T</tradeName>
    <deviceName>DC2 U3-3 Std Tq, DC U4-5 Std Tq, DC L3-3 Std Tq, DQ L4-5 Std Tq; Peerless Tubes on the 6's, Accent Mini &amp; Ortho Accent T</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>740-1508</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:29.147Z</lastUpdated>
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  <row>
    <udiDi>00889989062052</udiDi>
    <basicUdiDi>B-00889989062052</basicUdiDi>
    <tradeName>DC2 U3-3 Std Tq, DC U4-5 Std Tq, DC L3-3 Std Tq, DQ L4-5 Std Tq</tradeName>
    <deviceName>DC2 U3-3 Std Tq, DC U4-5 Std Tq, DC L3-3 Std Tq, DQ L4-5 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>740-1507</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:28.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989062045</udiDi>
    <basicUdiDi>B-00889989062045</basicUdiDi>
    <tradeName>DC2 U3-3 Std Tq, DC L3-3 Std Tq, DQ U/L4-5 Std Tq</tradeName>
    <deviceName>DC2 U3-3 Std Tq, DC L3-3 Std Tq, DQ U/L4-5 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>740-1506</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:27.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989062038</udiDi>
    <basicUdiDi>B-00889989062038</basicUdiDi>
    <tradeName>DQ SPK 5: U5-5 STD TQ, 6/7 Tubes</tradeName>
    <deviceName>DQ SPK 5: U5-5 STD TQ, 6/7 Tubes</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>740-1505</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:26.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989062021</udiDi>
    <basicUdiDi>B-00889989062021</basicUdiDi>
    <tradeName>DQ SPK 4: U3-3 HI TQ, U4-5 and L5-5 STD TQ</tradeName>
    <deviceName>DQ SPK 4: U3-3 HI TQ, U4-5 and L5-5 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>740-1504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:22.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989062014</udiDi>
    <basicUdiDi>B-00889989062014</basicUdiDi>
    <tradeName>DQ SPK 3: U/L 5-5 STD TQ</tradeName>
    <deviceName>DQ SPK 3: U/L 5-5 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>740-1503</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:21.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989062007</udiDi>
    <basicUdiDi>B-00889989062007</basicUdiDi>
    <tradeName>D3MX SPK 2: U/L 5-5 STD TQ; 6/7 Tubes</tradeName>
    <deviceName>D3MX SPK 2: U/L 5-5 STD TQ; 6/7 Tubes</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>740-1502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:21.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989061994</udiDi>
    <basicUdiDi>B-00889989061994</basicUdiDi>
    <tradeName>D3MX SPK 1: U/L 5-5 STD TQ</tradeName>
    <deviceName>D3MX SPK 1: U/L 5-5 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>740-1501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:20.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989061970</udiDi>
    <basicUdiDi>B-00889989061970</basicUdiDi>
    <tradeName>00889989061970</tradeName>
    <deviceName>TI-ORTHOS UP/LO HK 7x7 .022</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>740-1281</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:16.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989061963</udiDi>
    <basicUdiDi>B-00889989061963</basicUdiDi>
    <tradeName>00889989061963</tradeName>
    <deviceName>TI-ORTHOS UP/LO HK 7x7 .018</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>740-1280</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:15.533Z</lastUpdated>
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  <row>
    <udiDi>00889989061956</udiDi>
    <basicUdiDi>B-00889989061956</basicUdiDi>
    <tradeName>00889989061956</tradeName>
    <deviceName>TI-ORTHOS UP/LO HK 5x5 .022</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>740-1279</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:14.731Z</lastUpdated>
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  <row>
    <udiDi>00889989061949</udiDi>
    <basicUdiDi>B-00889989061949</basicUdiDi>
    <tradeName>00889989061949</tradeName>
    <deviceName>TI-ORTHOS UP/LO HK 5x5 .018</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>740-1278</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:13.929Z</lastUpdated>
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  <row>
    <udiDi>00889989061932</udiDi>
    <basicUdiDi>B-00889989061932</basicUdiDi>
    <tradeName>00889989061932</tradeName>
    <deviceName>ORTHOS CM UP/LO 5X5-.022</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>740-1247</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:09.938Z</lastUpdated>
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    <udiDi>00889989061925</udiDi>
    <basicUdiDi>B-00889989061925</basicUdiDi>
    <tradeName>00889989061925</tradeName>
    <deviceName>ORTHOS CM UP/LO 5X5-.018</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>740-1246</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:09.140Z</lastUpdated>
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    <udiDi>00889989061833</udiDi>
    <basicUdiDi>B-00889989061833</basicUdiDi>
    <tradeName>00889989061833</tradeName>
    <deviceName>ALIAS-LINGUAL BRACKET SYSTEM SPK UP/LO 7X7 .018</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>740-0430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:08.328Z</lastUpdated>
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    <udiDi>00889989061826</udiDi>
    <basicUdiDi>B-00889989061826</basicUdiDi>
    <tradeName>00889989061826</tradeName>
    <deviceName>STb STRAIGHTWIRE EXTRACTION UPPER 7x7 .018 SPK</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>740-0425</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:49:07.523Z</lastUpdated>
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