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<eudamedExport entity="devices">
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    <udiDi>00810000525737</udiDi>
    <basicUdiDi>B-00810000525737</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>Hyperfil® 3ml Enamel Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S235</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:14.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525720</udiDi>
    <basicUdiDi>B-00810000525720</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>Hyperfil® 3ml Universal Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:13.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525652</udiDi>
    <basicUdiDi>B-00810000525652</basicUdiDi>
    <tradeName>Predicta®</tradeName>
    <deviceName>Predicta® Bioactive Cement - White Opaque Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:12.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525645</udiDi>
    <basicUdiDi>B-00810000525645</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Cement</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S631</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:11.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525638</udiDi>
    <basicUdiDi>B-00810000525638</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Cement</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:07.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525539</udiDi>
    <basicUdiDi>B-00810000525539</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Desensitizer</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019008</emdnCode>
    <emdnDescription>DENTINAL DESENSITISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S626</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:06.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525461</udiDi>
    <basicUdiDi>B-00810000525461</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S616</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:06.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525454</udiDi>
    <basicUdiDi>B-00810000525454</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S615</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:38:05.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525447</udiDi>
    <basicUdiDi>B-00810000525447</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:55.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525430</udiDi>
    <basicUdiDi>B-00810000525430</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:54.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525423</udiDi>
    <basicUdiDi>B-00810000525423</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:53.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525416</udiDi>
    <basicUdiDi>B-00810000525416</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:52.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525409</udiDi>
    <basicUdiDi>B-00810000525409</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:48.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525393</udiDi>
    <basicUdiDi>B-00810000525393</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:47.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525324</udiDi>
    <basicUdiDi>B-00810000525324</basicUdiDi>
    <tradeName>Retrieve™</tradeName>
    <deviceName>Retrieve</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:47.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525249</udiDi>
    <basicUdiDi>B-00810000525249</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>10ml Universal Shade HyperFIL® - DC (Dual-Cure)</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S326</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:46.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525034</udiDi>
    <basicUdiDi>B-00810000525034</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin®</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:42.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525232</udiDi>
    <basicUdiDi>B-00810000525232</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>10ml Enamel Shade HyperFIL® - DC (Dual-Cure)</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:41.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525065</udiDi>
    <basicUdiDi>B-00810000525065</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin®</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:40.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525027</udiDi>
    <basicUdiDi>B-00810000525027</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:33:39.949Z</lastUpdated>
  </row>
</eudamedExport>