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<eudamedExport entity="devices">
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    <udiDi>00817441026939</udiDi>
    <basicUdiDi>B-00817441026939</basicUdiDi>
    <tradeName>00817441026939</tradeName>
    <deviceName>Dental Polymer Based Filling and Restorative 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>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:10:06.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022757</udiDi>
    <basicUdiDi>B-00817441022757</basicUdiDi>
    <tradeName>Prime-Dent Hema Desensitizer</tradeName>
    <deviceName>Prime-Dent Hema Desensitizer</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019008</emdnCode>
    <emdnDescription>DENTINAL DESENSITISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018-011</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:10:05.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441020999</udiDi>
    <basicUdiDi>B-00817441020999</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Micro-Hybrid Composite</tradeName>
    <deviceName>VLC Micro-Hybrid Composite 4 Syringe Kit</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-414</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:10:01.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441020982</udiDi>
    <basicUdiDi>B-00817441020982</basicUdiDi>
    <tradeName>Prime-Dent</tradeName>
    <deviceName>VLC Micro-Hybrid Composite 7 Syringe Kit</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-410</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:10:00.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441020517</udiDi>
    <basicUdiDi>B-00817441020517</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Hybrid Composite</tradeName>
    <deviceName>Prime-Dent Light Cure Hybrid Composite - 4.5 g Syringe Refill [A1]</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>001-001A1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:09:59.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023440</udiDi>
    <basicUdiDi>081744102TF165J</basicUdiDi>
    <tradeName>Prime Dent Light Cure Dental Dam</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021-011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:41:32.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023457</udiDi>
    <basicUdiDi>081744102TF165J</basicUdiDi>
    <tradeName>Prime Dent Light Cure Dental Dam - 3.5gm Syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:41:32.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023211</udiDi>
    <basicUdiDi>081744102TF1056</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Pit and Fissure Sealant</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007-022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:23:56.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441026618</udiDi>
    <basicUdiDi>081744102TF165J</basicUdiDi>
    <tradeName>Prime-Dent Alginate Flavoring</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01020101</emdnCode>
    <emdnDescription>DENTAL IMPRESSION ALGINATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:43.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441026052</udiDi>
    <basicUdiDi>081744102TF055D</basicUdiDi>
    <tradeName>Prime-Dent Prime-Dent Automix Dual Cure Core Build-Up Material</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:42.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023778</udiDi>
    <basicUdiDi>081744102TF095M</basicUdiDi>
    <tradeName>Prime-Dent VLC Orthodontic Adhesive Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q010407</emdnCode>
    <emdnDescription>ORTHODONTIC CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:40.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023631</udiDi>
    <basicUdiDi>0817441023631TY</basicUdiDi>
    <tradeName>Prime-Paste</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12119007</emdnCode>
    <emdnDescription>DENTAL PROPHYLAXIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:39.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023433</udiDi>
    <basicUdiDi>081744102TF175L</basicUdiDi>
    <tradeName>Prime-Dent Impression Tray Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01020199</emdnCode>
    <emdnDescription>DENTAL IMPRESSION MATERIALS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:38.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023341</udiDi>
    <basicUdiDi>081744102TF065F</basicUdiDi>
    <tradeName>Prime Dent Prime-Dent Root Canal Filling Material</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:37.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022931</udiDi>
    <basicUdiDi>081744102TF008XS</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:35.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022818</udiDi>
    <basicUdiDi>081744102TF8DB</basicUdiDi>
    <tradeName>Prime-Dent</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:35:34.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022658</udiDi>
    <basicUdiDi>081744102TF0257</basicUdiDi>
    <tradeName>Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q01010104</emdnCode>
    <emdnDescription>DENTAL BONDING AGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:31:03.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022382</udiDi>
    <basicUdiDi>081744102TF045B</basicUdiDi>
    <tradeName>Prime-Dent Prime-Dent Dual Cure Composite Luting Cement</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:31:02.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022276</udiDi>
    <basicUdiDi>081744102TF135C</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:31:01.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022160</udiDi>
    <basicUdiDi>081744102TF075H</basicUdiDi>
    <tradeName>Prime-Dent Automix Non Eugenol Temporary Cement</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Q0101010203</emdnCode>
    <emdnDescription>TEMPORARY DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:31:00.618Z</lastUpdated>
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</eudamedExport>