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    <udiDi>10810000527608</udiDi>
    <basicUdiDi>081000052NEEDLETIPFU</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Dispensing Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S621</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:53.598Z</lastUpdated>
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  <row>
    <udiDi>10810000527561</udiDi>
    <basicUdiDi>081000052APPBRUSH84</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Applicator Brush</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S379</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:52.006Z</lastUpdated>
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  <row>
    <udiDi>10810000526977</udiDi>
    <basicUdiDi>081000052MIXINGTIP3JZ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 3</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S439IOT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:51.196Z</lastUpdated>
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    <udiDi>10810000526960</udiDi>
    <basicUdiDi>081000052NEEDLETIP4ZK</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Application Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S383</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:49.600Z</lastUpdated>
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    <udiDi>10810000526861</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing/Dispensing Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:47.203Z</lastUpdated>
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  <row>
    <udiDi>10810000526854</udiDi>
    <basicUdiDi>081000052MIXINGTIP4K3</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 4</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:45.592Z</lastUpdated>
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  <row>
    <udiDi>10810000526847</udiDi>
    <basicUdiDi>081000052MIXINGTIP2JX</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 2</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:44.791Z</lastUpdated>
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  <row>
    <udiDi>10810000526830</udiDi>
    <basicUdiDi>081000052NEEDLETIP2ZF</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Pre-Bent Needle Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:43.190Z</lastUpdated>
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    <udiDi>10810000526809</udiDi>
    <basicUdiDi>081000052NEEDLETIP3ZH</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Luer Lock Applicator Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:40.788Z</lastUpdated>
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  <row>
    <udiDi>10304040132217</udiDi>
    <basicUdiDi>03040444801DH</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Microtip applicators</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5702048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:21.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700425908819</udiDi>
    <basicUdiDi>03700425NS-classI-007WD</basicUdiDi>
    <tradeName>Micros applicateurs standard vert /4800</tradeName>
    <deviceName>Embout</deviceName>
    <manufacturerName>MEDISTOCK</manufacturerName>
    <manufacturerSrn>FR-MF-000007667</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K50031G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:15:07.855Z</lastUpdated>
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  <row>
    <udiDi>00856402006061</udiDi>
    <basicUdiDi>00856402BioGreenT9</basicUdiDi>
    <tradeName>BioGreen Micro-Applicator - Regular</tradeName>
    <deviceName>BioGreen</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3005100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:37:04.424Z</lastUpdated>
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  <row>
    <udiDi>00810118106637</udiDi>
    <basicUdiDi>00883205034BFT20EP</basicUdiDi>
    <tradeName>Dentsply ProRoot Flex Tip</tradeName>
    <deviceName>Basic Flex Tip</deviceName>
    <manufacturerName>NuSmile, Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000021910</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRFT20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:33:26.559Z</lastUpdated>
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  <row>
    <udiDi>00348783002010</udiDi>
    <basicUdiDi>00348783Trax-ItenaTipXJ</basicUdiDi>
    <tradeName>Itena Traxodent Applicator Tip Qty 60</tradeName>
    <deviceName>Itena Traxodent Tips</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7007092 (TRAEMB-60)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:02:46.209Z</lastUpdated>
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    <udiDi>00348783002003</udiDi>
    <basicUdiDi>00348783TraxodentTipsP9</basicUdiDi>
    <tradeName>Traxodent Applicator Tip</tradeName>
    <deviceName>Traxodent Tips</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9007092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:02:44.402Z</lastUpdated>
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    <udiDi>00348783005134</udiDi>
    <basicUdiDi>00348783RC-PrepTipsRC</basicUdiDi>
    <tradeName>RC PREP PLASTIC 9G SYR TIP REFILL (50)</tradeName>
    <deviceName>RC-Prep Tips</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9007127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:58:51.952Z</lastUpdated>
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    <udiDi>00348783003765</udiDi>
    <basicUdiDi>00348783PICTipsX8</basicUdiDi>
    <tradeName>AUTO DUAL BARREL SYRINGE TIPS (25)</tradeName>
    <deviceName>PIC Tips</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001451</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:58:45.444Z</lastUpdated>
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    <udiDi>00348783003758</udiDi>
    <basicUdiDi>00348783CompCoreAFTipsPU</basicUdiDi>
    <tradeName>Syringe Mix-tip Refill</tradeName>
    <deviceName>CompCore AF Tips</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001418</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:58:44.771Z</lastUpdated>
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    <udiDi>D7792031040</udiDi>
    <basicUdiDi>++D779LUERLOCKTIPS7B</basicUdiDi>
    <tradeName>D7792031040</tradeName>
    <deviceName>Luer Lock Tip</deviceName>
    <manufacturerName>Cosmedent, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045496</manufacturerSrn>
    <authorisedRepresentativeName>SAS Exclusivas Dentales S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000045423</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>203104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:57.320Z</lastUpdated>
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    <udiDi>D7792012110</udiDi>
    <basicUdiDi>++D779BRUSH101CD</basicUdiDi>
    <tradeName>Black Brush #1 Bent</tradeName>
    <deviceName>Black Brush</deviceName>
    <manufacturerName>Cosmedent, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045496</manufacturerSrn>
    <authorisedRepresentativeName>SAS Exclusivas Dentales S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000045423</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201211</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:56.010Z</lastUpdated>
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