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<eudamedExport entity="devices">
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    <udiDi>00817441022221</udiDi>
    <basicUdiDi>B-00817441022221</basicUdiDi>
    <tradeName>Prime-Dent Polycarboxylate Cement</tradeName>
    <deviceName>Prime-Dent Polycarboxylate Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:07.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022214</udiDi>
    <basicUdiDi>B-00817441022214</basicUdiDi>
    <tradeName>Prime-Dent Polycarboxylate Cement</tradeName>
    <deviceName>Prime-Dent Polycarboxylate Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:03.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022207</udiDi>
    <basicUdiDi>B-00817441022207</basicUdiDi>
    <tradeName>Prime-Dent Polycarboxylate Cement</tradeName>
    <deviceName>Prime-Dent Polycarboxylate Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:02.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022191</udiDi>
    <basicUdiDi>B-00817441022191</basicUdiDi>
    <tradeName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</tradeName>
    <deviceName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023-011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:01.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022184</udiDi>
    <basicUdiDi>B-00817441022184</basicUdiDi>
    <tradeName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</tradeName>
    <deviceName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:00.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022177</udiDi>
    <basicUdiDi>B-00817441022177</basicUdiDi>
    <tradeName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</tradeName>
    <deviceName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023-014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:56.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022153</udiDi>
    <basicUdiDi>B-00817441022153</basicUdiDi>
    <tradeName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</tradeName>
    <deviceName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023-013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:55.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022146</udiDi>
    <basicUdiDi>B-00817441022146</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Cement</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:55.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022139</udiDi>
    <basicUdiDi>B-00817441022139</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Cement</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:54.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022122</udiDi>
    <basicUdiDi>B-00817441022122</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Cement</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:50.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022108</udiDi>
    <basicUdiDi>B-00817441022108</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:49.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022092</udiDi>
    <basicUdiDi>B-00817441022092</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:48.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022085</udiDi>
    <basicUdiDi>B-00817441022085</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:47.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022078</udiDi>
    <basicUdiDi>B-00817441022078</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:44.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022061</udiDi>
    <basicUdiDi>B-00817441022061</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:43.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022054</udiDi>
    <basicUdiDi>B-00817441022054</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:42.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441021705</udiDi>
    <basicUdiDi>B-00817441021705</basicUdiDi>
    <tradeName>Parafil Primer</tradeName>
    <deviceName>Parafil Primer</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9999-7230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:41.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441021699</udiDi>
    <basicUdiDi>B-00817441021699</basicUdiDi>
    <tradeName>Parafil Primer</tradeName>
    <deviceName>Parafil Primer</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9999-7220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:59:37.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022115</udiDi>
    <basicUdiDi>B-00817441022115</basicUdiDi>
    <tradeName>Prime-Dent Glass Ionomer Cement</tradeName>
    <deviceName>Glass Ionomer Cement Kit 18 g Powder/17.5ml Liquid</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010-020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:47.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022382</udiDi>
    <basicUdiDi>B-00817441022382</basicUdiDi>
    <tradeName>Prime Dent Automix System Dual Cure Composite Luting Cement</tradeName>
    <deviceName>Prime-Dent Dual Cure Composite Luting Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:46.569Z</lastUpdated>
  </row>
</eudamedExport>