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    <tradeName>Prime-Dent Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent 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>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Prime-Dent Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent Dual Cure Composite Resin Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
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    <tradeName>Prime-Dent Dual Cure Composite Resin Cement</tradeName>
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    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
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    <tradeName>Prime-Dent Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent Dual Cure Composite Resin Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-08-07T05:11:28.146Z</lastUpdated>
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    <tradeName>Prime-Dent Dual Cure Composite Resin Cement</tradeName>
    <deviceName>Prime-Dent Dual Cure Composite Resin Cement</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <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>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:24.152Z</lastUpdated>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ENAMEL-DENTINAL ETCHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008-052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:22.536Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Light Cured Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9999LR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:21.747Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Light Cured 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>
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    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9998C4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:20.141Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Light Cured 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>
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    <emdnCode>Q0101010201</emdnCode>
    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9998C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:17.735Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Light Cured Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:16.147Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
    <deviceName>Prime-Dent Light Cured Glass Ionomer Restorative</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9998B3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:15.332Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
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    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
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    <emdnDescription>DENTAL BASE CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9998B2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:11:13.733Z</lastUpdated>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
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    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <tradeName>Prime-Dent Light Cured Glass Ionomer Restorative</tradeName>
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    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9999C2</reference>
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