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    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.234Z</lastUpdated>
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    <udiDi>10810000524225</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Blu-Mousse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>DryZ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>DryZ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S187</reference>
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    <udiDi>10810000525161</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>DryZ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.039Z</lastUpdated>
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    <udiDi>10810000525710</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>Simplee®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>156215</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.975Z</lastUpdated>
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    <udiDi>10810000526083</udiDi>
    <basicUdiDi>081000052AFI&amp;IICY</basicUdiDi>
    <tradeName>AccuFilm I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020201</emdnCode>
    <emdnDescription>ARTICULATION PAPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.906Z</lastUpdated>
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    <udiDi>10810000526090</udiDi>
    <basicUdiDi>081000052AFI&amp;IICY</basicUdiDi>
    <tradeName>AccuFilm II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ARTICULATION PAPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.885Z</lastUpdated>
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    <udiDi>10810000526106</udiDi>
    <basicUdiDi>081000052AFI&amp;IICY</basicUdiDi>
    <tradeName>AccuFilm II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020201</emdnCode>
    <emdnDescription>ARTICULATION PAPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.866Z</lastUpdated>
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  <row>
    <udiDi>10810000526120</udiDi>
    <basicUdiDi>081000052AFI&amp;IICY</basicUdiDi>
    <tradeName>AccuFilm II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020201</emdnCode>
    <emdnDescription>ARTICULATION PAPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.851Z</lastUpdated>
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    <udiDi>10810000526144</udiDi>
    <basicUdiDi>081000052AFI&amp;IICY</basicUdiDi>
    <tradeName>AccuFilm II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020201</emdnCode>
    <emdnDescription>ARTICULATION PAPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S053</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000526878</udiDi>
    <basicUdiDi>081000052MIXINGTIP2JX</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.743Z</lastUpdated>
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  <row>
    <udiDi>10810000526885</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S308</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.721Z</lastUpdated>
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  <row>
    <udiDi>10810000526908</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.693Z</lastUpdated>
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    <udiDi>10810000526915</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.658Z</lastUpdated>
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    <udiDi>10810000526922</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S334</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.632Z</lastUpdated>
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    <udiDi>10810000526939</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S335</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.603Z</lastUpdated>
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    <udiDi>10810000526991</udiDi>
    <basicUdiDi>081000052MIXINGTIP3JZ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.535Z</lastUpdated>
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    <udiDi>10810000527004</udiDi>
    <basicUdiDi>081000052MIXINGTIP3JZ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S472</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.512Z</lastUpdated>
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    <udiDi>10810000527011</udiDi>
    <basicUdiDi>081000052MIXINGTIP3JZ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S496</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.492Z</lastUpdated>
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