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    <basicUdiDi>B-00817441022658</basicUdiDi>
    <tradeName>Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Bonding Agents</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>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>006-030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:45.798Z</lastUpdated>
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    <udiDi>00817441026052</udiDi>
    <basicUdiDi>B-00817441026052</basicUdiDi>
    <tradeName>Prime-Dent Automix Dual Cure Core Build-Up Material</tradeName>
    <deviceName>Dental Core Build Up Materials</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>003-082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:45.281Z</lastUpdated>
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  <row>
    <udiDi>00817441023341</udiDi>
    <basicUdiDi>B-00817441023341</basicUdiDi>
    <tradeName>Prime-Dent Root Canal Filling Material</tradeName>
    <deviceName>Dental Root Canal Filling Materials</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>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022-010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:45.134Z</lastUpdated>
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    <udiDi>00817441022160</udiDi>
    <basicUdiDi>B-00817441022160</basicUdiDi>
    <tradeName>Prime-Dent Resin Based Non-Eugenol Temporary Cement</tradeName>
    <deviceName>Dental Temporary Cements</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>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023-012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:45.050Z</lastUpdated>
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  <row>
    <udiDi>00817441022818</udiDi>
    <basicUdiDi>B-00817441022818</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel</tradeName>
    <deviceName>Etchant Gel</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>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:44.915Z</lastUpdated>
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  <row>
    <udiDi>00817441022931</udiDi>
    <basicUdiDi>B-00817441022931</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel</tradeName>
    <deviceName>Etchant Gel</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>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-07T03:49:44.696Z</lastUpdated>
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  <row>
    <udiDi>00817441027202</udiDi>
    <basicUdiDi>B-00817441027202</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-619DXWL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:22.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441027196</udiDi>
    <basicUdiDi>B-00817441027196</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-619EXWL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:22.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441024201</udiDi>
    <basicUdiDi>B-00817441024201</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-019C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:21.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441024195</udiDi>
    <basicUdiDi>B-00817441024195</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-019B4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:17.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023884</udiDi>
    <basicUdiDi>B-00817441023884</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Micro Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Micro Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-401O</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:16.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441021774</udiDi>
    <basicUdiDi>B-00817441021774</basicUdiDi>
    <tradeName>Parafil Gingiva</tradeName>
    <deviceName>Parafil Gingiva</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9999-GM22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:15.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441027219</udiDi>
    <basicUdiDi>B-00817441027219</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-619HW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:05:12.581Z</lastUpdated>
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  <row>
    <udiDi>00817441027189</udiDi>
    <basicUdiDi>B-00817441027189</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-619BW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:05:07.765Z</lastUpdated>
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    <udiDi>00817441027165</udiDi>
    <basicUdiDi>B-00817441027165</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-601HW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:05:07.069Z</lastUpdated>
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    <udiDi>00817441027158</udiDi>
    <basicUdiDi>B-00817441027158</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-601DXWL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:04:50.902Z</lastUpdated>
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    <udiDi>00817441027141</udiDi>
    <basicUdiDi>B-00817441027141</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-601EXWL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:04:50.089Z</lastUpdated>
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    <udiDi>00817441027134</udiDi>
    <basicUdiDi>B-00817441027134</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-601BW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:04:49.288Z</lastUpdated>
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    <udiDi>00817441027127</udiDi>
    <basicUdiDi>B-00817441027127</basicUdiDi>
    <tradeName>Prime-Dent Visible Light Cure Nano Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Visible Light Cure Nano Hybrid Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-601T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:04:48.505Z</lastUpdated>
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    <udiDi>00817441025949</udiDi>
    <basicUdiDi>B-00817441025949</basicUdiDi>
    <tradeName>Prime-Dent Chemical Cure Composite</tradeName>
    <deviceName>Prime-Dent Chemical Cure Composite</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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002-059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:04:44.502Z</lastUpdated>
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