<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817441023235</udiDi>
    <basicUdiDi>B-00817441023235</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Pit and Fissure Sealant</tradeName>
    <deviceName>Prime-Dent Light Cure Pit and Fissure 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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007-022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:59:07.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023228</udiDi>
    <basicUdiDi>B-00817441023228</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Pit and Fissure Sealant</tradeName>
    <deviceName>Prime-Dent Light Cure Pit and Fissure 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>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007-021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:59:06.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022771</udiDi>
    <basicUdiDi>B-00817441022771</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019008</emdnCode>
    <emdnDescription>DENTINAL DESENSITISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018-031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:59:05.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022764</udiDi>
    <basicUdiDi>B-00817441022764</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019008</emdnCode>
    <emdnDescription>DENTINAL DESENSITISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018-030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:59:00.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022375</udiDi>
    <basicUdiDi>B-00817441022375</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104B2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:59:00.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022368</udiDi>
    <basicUdiDi>B-00817441022368</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104B1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:59.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022351</udiDi>
    <basicUdiDi>B-00817441022351</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104A3.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:58.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022344</udiDi>
    <basicUdiDi>B-00817441022344</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104A3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:54.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022337</udiDi>
    <basicUdiDi>B-00817441022337</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104A2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:53.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022320</udiDi>
    <basicUdiDi>B-00817441022320</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-104A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:52.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022313</udiDi>
    <basicUdiDi>B-00817441022313</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103B2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:52.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022306</udiDi>
    <basicUdiDi>B-00817441022306</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103B1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:48.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022290</udiDi>
    <basicUdiDi>B-00817441022290</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103A3.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:47.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022283</udiDi>
    <basicUdiDi>B-00817441022283</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103A3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:45.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022269</udiDi>
    <basicUdiDi>B-00817441022269</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Prime-Crown</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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:58:44.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441023778</udiDi>
    <basicUdiDi>B-00817441023778</basicUdiDi>
    <tradeName>Prime-Dent Light Cure Orthodontic Adhesive</tradeName>
    <deviceName>Orthodontic Adhesives</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>Q010407</emdnCode>
    <emdnDescription>ORTHODONTIC CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>012-020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:11.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441022276</udiDi>
    <basicUdiDi>B-00817441022276</basicUdiDi>
    <tradeName>Prime-Crown</tradeName>
    <deviceName>Dental Temporary Crown and Bridge 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>Q0102050101</emdnCode>
    <emdnDescription>TEMPORARY TEETH RESINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-103A2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:09.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850086738072</udiDi>
    <basicUdiDi>B-00850086738072</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>006-020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:12:16.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441029336</udiDi>
    <basicUdiDi>B-00817441029336</basicUdiDi>
    <tradeName>Prime-Dent Automix Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent Automix Dual Cure Composite Resin 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>015-029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:49.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817441029343</udiDi>
    <basicUdiDi>B-00817441029343</basicUdiDi>
    <tradeName>Prime-Dent Automix Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent Automix Dual Cure Composite Resin 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>015-040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:46.704Z</lastUpdated>
  </row>
</eudamedExport>