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    <tradeName>Parafil Stain</tradeName>
    <deviceName>Parafil Stain</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>9999-71YE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:11.622Z</lastUpdated>
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    <udiDi>00817441021873</udiDi>
    <basicUdiDi>B-00817441021873</basicUdiDi>
    <tradeName>Parafil Stain</tradeName>
    <deviceName>Parafil Stain</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>9999-71BR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:10.896Z</lastUpdated>
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    <udiDi>00817441021866</udiDi>
    <basicUdiDi>B-00817441021866</basicUdiDi>
    <tradeName>Parafil Stain</tradeName>
    <deviceName>Parafil Stain</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>9999-71BL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:10.029Z</lastUpdated>
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    <udiDi>00817441021859</udiDi>
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    <tradeName>Parafil Stain</tradeName>
    <deviceName>Parafil Stain</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>9999-71BE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:05.218Z</lastUpdated>
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    <udiDi>00817441021842</udiDi>
    <basicUdiDi>B-00817441021842</basicUdiDi>
    <tradeName>Parafil Stain</tradeName>
    <deviceName>Parafil Stain</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>9999-7300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:04.419Z</lastUpdated>
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    <udiDi>00817441021835</udiDi>
    <basicUdiDi>B-00817441021835</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-GOM2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:03.618Z</lastUpdated>
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    <udiDi>00817441021828</udiDi>
    <basicUdiDi>B-00817441021828</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-GO12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:55:02.818Z</lastUpdated>
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    <udiDi>00817441021811</udiDi>
    <basicUdiDi>B-00817441021811</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>9999-9G23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:58.811Z</lastUpdated>
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    <udiDi>00817441021804</udiDi>
    <basicUdiDi>B-00817441021804</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>9999-9G22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:58.016Z</lastUpdated>
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    <udiDi>00817441021798</udiDi>
    <basicUdiDi>B-00817441021798</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>9999-9G21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:57.216Z</lastUpdated>
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    <udiDi>00817441021781</udiDi>
    <basicUdiDi>B-00817441021781</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-GM23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:56.411Z</lastUpdated>
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    <udiDi>00817441021767</udiDi>
    <basicUdiDi>B-00817441021767</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-GM21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:51.609Z</lastUpdated>
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    <udiDi>00817441021750</udiDi>
    <basicUdiDi>B-00817441021750</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>9999-7100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:50.907Z</lastUpdated>
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    <udiDi>00817441021743</udiDi>
    <basicUdiDi>B-00817441021743</basicUdiDi>
    <tradeName>Parafil Modeler</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>9999-7260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:38.720Z</lastUpdated>
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    <udiDi>00817441021736</udiDi>
    <basicUdiDi>B-00817441021736</basicUdiDi>
    <tradeName>Parafil Modifier</tradeName>
    <deviceName>Parafil Modifier</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>9999-7250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:34.738Z</lastUpdated>
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    <udiDi>00817441021729</udiDi>
    <basicUdiDi>B-00817441021729</basicUdiDi>
    <tradeName>Parafil Separator</tradeName>
    <deviceName>Parafil Separator</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>9999-7241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:33.933Z</lastUpdated>
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    <udiDi>00817441021712</udiDi>
    <basicUdiDi>B-00817441021712</basicUdiDi>
    <tradeName>Parafil Separator</tradeName>
    <deviceName>Parafil Separator</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>9999-7240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:33.133Z</lastUpdated>
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    <udiDi>00817441021675</udiDi>
    <basicUdiDi>B-00817441021675</basicUdiDi>
    <tradeName>Parafil Lab</tradeName>
    <deviceName>Parafil Lab</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>9999-7001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:32.332Z</lastUpdated>
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    <udiDi>00817441021668</udiDi>
    <basicUdiDi>B-00817441021668</basicUdiDi>
    <tradeName>Parafil Lab</tradeName>
    <deviceName>Parafil Lab</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>9999-7000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:27.533Z</lastUpdated>
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    <udiDi>00817441021651</udiDi>
    <basicUdiDi>B-00817441021651</basicUdiDi>
    <tradeName>Parafil Lab</tradeName>
    <deviceName>Parafil Lab</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>9999-70OTG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:54:26.734Z</lastUpdated>
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