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<eudamedExport entity="devices">
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    <udiDi>00817441022856</udiDi>
    <basicUdiDi>B-00817441022856</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel</tradeName>
    <deviceName>Prime-Dent 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>MDD</legislation>
    <emdnCode>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:48.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022832</udiDi>
    <basicUdiDi>B-00817441022832</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel</tradeName>
    <deviceName>Prime-Dent 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>MDD</legislation>
    <emdnCode>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:46.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022825</udiDi>
    <basicUdiDi>B-00817441022825</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel Silica-Free</tradeName>
    <deviceName>Prime-Dent Etchant Gel Silica-Free</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>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-010SF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:44.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022849</udiDi>
    <basicUdiDi>B-00817441022849</basicUdiDi>
    <tradeName>Prime-Dent Etchant Gel Silica-Free</tradeName>
    <deviceName>Prime-Dent Etchant Gel Silica-Free</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>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-011SF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:32.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022801</udiDi>
    <basicUdiDi>B-00817441022801</basicUdiDi>
    <tradeName>Prime-Dent Porcelain Etch Gel</tradeName>
    <deviceName>Prime-Dent Porcelain Etch 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>MDD</legislation>
    <emdnCode>Q01010402</emdnCode>
    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:16.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022795</udiDi>
    <basicUdiDi>B-00817441022795</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Surface Sealant</tradeName>
    <deviceName>Prime-Dent Light Cure Surface Sealant</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>005-011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:14.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022788</udiDi>
    <basicUdiDi>B-00817441022788</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Surface Sealant</tradeName>
    <deviceName>Prime-Dent Light Cure Surface Sealant</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>005-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:13.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022740</udiDi>
    <basicUdiDi>B-00817441022740</basicUdiDi>
    <tradeName>Prime Blend Ultra</tradeName>
    <deviceName>Prime Blend Ultra</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>200-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:12.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022733</udiDi>
    <basicUdiDi>B-00817441022733</basicUdiDi>
    <tradeName>Prime Blend Ultra</tradeName>
    <deviceName>Prime Blend Ultra</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>200-000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:09.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022726</udiDi>
    <basicUdiDi>B-00817441022726</basicUdiDi>
    <tradeName>Prime Blend Ultra</tradeName>
    <deviceName>Prime Blend Ultra</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>200-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:08.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022719</udiDi>
    <basicUdiDi>B-00817441022719</basicUdiDi>
    <tradeName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</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>006-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:07.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022702</udiDi>
    <basicUdiDi>B-00817441022702</basicUdiDi>
    <tradeName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</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>006-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:05.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022696</udiDi>
    <basicUdiDi>B-00817441022696</basicUdiDi>
    <tradeName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive</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>006-021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:03.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022689</udiDi>
    <basicUdiDi>B-00817441022689</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive</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>006-018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:01.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022672</udiDi>
    <basicUdiDi>B-00817441022672</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive</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>006-019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:01:00.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022665</udiDi>
    <basicUdiDi>B-00817441022665</basicUdiDi>
    <tradeName>Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive</tradeName>
    <deviceName>Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive</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>006-032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:59.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022641</udiDi>
    <basicUdiDi>B-00817441022641</basicUdiDi>
    <tradeName>Prime-Dent Zinc Oxide Eugenol Reinforced Cement</tradeName>
    <deviceName>Prime-Dent Zinc Oxide Eugenol Reinforced 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>010-092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:57.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022634</udiDi>
    <basicUdiDi>B-00817441022634</basicUdiDi>
    <tradeName>Prime-Dent Zinc Oxide Eugenol Reinforced Cement</tradeName>
    <deviceName>Prime-Dent Zinc Oxide Eugenol Reinforced 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>010-091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:55.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022627</udiDi>
    <basicUdiDi>B-00817441022627</basicUdiDi>
    <tradeName>Prime-Dent Zinc Oxide Eugenol Reinforced Cement</tradeName>
    <deviceName>Prime-Dent Zinc Oxide Eugenol Reinforced 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>010-090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:54.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022610</udiDi>
    <basicUdiDi>B-00817441022610</basicUdiDi>
    <tradeName>Prime-Dent Zinc Oxide Eugenol Cement</tradeName>
    <deviceName>Prime-Dent Zinc Oxide Eugenol 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>010-082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:00:52.870Z</lastUpdated>
  </row>
</eudamedExport>