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    <deviceName>5-5 U/L DAMON Q SINGLE PATIENT KIT: U3-3 HIGH TQ, L2-2 LOW TQ</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <deviceName>5-5 U/L DAMON Q SINGLE PATIENT KIT: U2-2 LOW</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
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    <reference>740-1401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <deviceName>5-5 U/L DAMON Q SINGLE PATIENT KIT: 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>
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    <lastUpdated>2026-07-05T12:51:03.695Z</lastUpdated>
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    <basicUdiDi>B-00889989080186</basicUdiDi>
    <tradeName>TWNBKT DMD MED LAT  +7TRQ +8ANG 022LT</tradeName>
    <deviceName>TWNBKT DMD MED LAT  +7TRQ +8ANG 022LT</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>112-0421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:51:02.901Z</lastUpdated>
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    <udiDi>00889989079982</udiDi>
    <basicUdiDi>B-00889989079982</basicUdiDi>
    <tradeName>INSIGNIA ICE  3 - 3 KIT</tradeName>
    <deviceName>INSIGNIA ICE  3 - 3 KIT</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>728-0020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:58.904Z</lastUpdated>
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    <udiDi>00889989079975</udiDi>
    <basicUdiDi>B-00889989079975</basicUdiDi>
    <tradeName>INSIGNIA - BRACKET REPLACEMENT KIT</tradeName>
    <deviceName>INSIGNIA - BRACKET REPLACEMENT KIT</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>728-0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:58.093Z</lastUpdated>
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    <udiDi>00889989080070</udiDi>
    <basicUdiDi>B-00889989080070</basicUdiDi>
    <tradeName>00889989080070</tradeName>
    <deviceName>PROTECH GLASS ION.CEM.LIQ120ML 2-1210</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0153</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:57.291Z</lastUpdated>
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    <udiDi>00889989079999</udiDi>
    <basicUdiDi>B-00889989079999</basicUdiDi>
    <tradeName>INSIGNIA ICE  5 - 5 KIT</tradeName>
    <deviceName>INSIGNIA ICE  5 - 5 KIT</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>728-0021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:56.498Z</lastUpdated>
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    <udiDi>00889989079968</udiDi>
    <basicUdiDi>B-00889989079968</basicUdiDi>
    <tradeName>Insignia Kit</tradeName>
    <deviceName>Insignia Kit</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>728-0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:39.643Z</lastUpdated>
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    <udiDi>00889989075502</udiDi>
    <basicUdiDi>B-00889989075502</basicUdiDi>
    <tradeName>00889989075502</tradeName>
    <deviceName>PROTECH GLASS ION.CEM.POWD240G 2-1210</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-1151</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:38.841Z</lastUpdated>
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    <udiDi>00889989075496</udiDi>
    <basicUdiDi>B-00889989075496</basicUdiDi>
    <tradeName>00889989075496</tradeName>
    <deviceName>REFILL UNIDOSE - GRENGLOO</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0323</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:38.037Z</lastUpdated>
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    <udiDi>00889989075489</udiDi>
    <basicUdiDi>B-00889989075489</basicUdiDi>
    <tradeName>00889989075489</tradeName>
    <deviceName>Grenloo Unidose Kit</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0322</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:37.237Z</lastUpdated>
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    <udiDi>00889989075472</udiDi>
    <basicUdiDi>B-00889989075472</basicUdiDi>
    <tradeName>00889989075472</tradeName>
    <deviceName>REFILL SYRINGE - GRENGLOO</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0321</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:33.247Z</lastUpdated>
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    <udiDi>00889989075465</udiDi>
    <basicUdiDi>B-00889989075465</basicUdiDi>
    <tradeName>00889989075465</tradeName>
    <deviceName>Grengloo Syringe Kit</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0320</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:32.437Z</lastUpdated>
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    <udiDi>00889989075427</udiDi>
    <basicUdiDi>B-00889989075427</basicUdiDi>
    <tradeName>00889989075427</tradeName>
    <deviceName>OPTIBAND ULTRA, 10 SYRINGE KIT, BLUE COLOR  2-1491</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0294</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:31.639Z</lastUpdated>
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    <udiDi>00889989075410</udiDi>
    <basicUdiDi>B-00889989075410</basicUdiDi>
    <tradeName>00889989075410</tradeName>
    <deviceName>OPTIBAND ULTRA, 5 SYRINGE KIT, BLUE COLOR  2-1491</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0293</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:30.839Z</lastUpdated>
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    <basicUdiDi>B-00889989075403</basicUdiDi>
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    <deviceName>OPTIBAND ULTRA, 10 SYRINGE KIT, TOOTH COLOR  2-1491</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0292</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:26.826Z</lastUpdated>
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    <tradeName>00889989075397</tradeName>
    <deviceName>OPTIBAND ULTRA, 5 SYRINGE KIT, TOOTH COLOR  2-1491</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
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    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0291</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:26.030Z</lastUpdated>
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    <basicUdiDi>B-00889989075373</basicUdiDi>
    <tradeName>00889989075373</tradeName>
    <deviceName>Blugloo Unidose Kit</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0275</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:25.229Z</lastUpdated>
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    <basicUdiDi>B-00889989075366</basicUdiDi>
    <tradeName>00889989075366</tradeName>
    <deviceName>Blugloo Syringe Kit</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-0274</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:50:24.428Z</lastUpdated>
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