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<eudamedExport entity="devices">
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    <udiDi>00883205103499</udiDi>
    <basicUdiDi>0883205-TF049B9</basicUdiDi>
    <tradeName>OraSeal Caulking Refill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultradent Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013697</manufacturerSrn>
    <authorisedRepresentativeName>Ultradent Products GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006666</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:17:26.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00883205103543</udiDi>
    <basicUdiDi>0883205-TF049B9</basicUdiDi>
    <tradeName>OraSeal Putty Econo Refill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultradent Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013697</manufacturerSrn>
    <authorisedRepresentativeName>Ultradent Products GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006666</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>355</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:17:26.619Z</lastUpdated>
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  <row>
    <udiDi>08435567315335</udiDi>
    <basicUdiDi>084355673CASTCD</basicUdiDi>
    <tradeName>08435567315335</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Phibo Dental Solutions S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000024464</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019005</emdnCode>
    <emdnDescription>CASTABLE DENTAL POSTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>016.3100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:21:40.623Z</lastUpdated>
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  <row>
    <udiDi>00840221637704</udiDi>
    <basicUdiDi>08402216STRIPINT42</basicUdiDi>
    <tradeName>NeoDiamond</tradeName>
    <deviceName>Diamond Coated Dental Flexible Strips</deviceName>
    <manufacturerName>Microcopy, A Division of Neo-Flo, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012637</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019003</emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSS-25M-MS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:59:17.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818963020078</udiDi>
    <basicUdiDi>081896302DRDRYD7</basicUdiDi>
    <tradeName>DrDrys</tradeName>
    <deviceName>Saliva Absorbents   - Non Sterile</deviceName>
    <manufacturerName>Microcopy, A Division of Neo-Flo, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012637</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRDRYL</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:49.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818963020016</udiDi>
    <basicUdiDi>081896302DYSKS</basicUdiDi>
    <tradeName>NeoDry</tradeName>
    <deviceName>Saliva Absorbents   - Non Sterile</deviceName>
    <manufacturerName>Microcopy, A Division of Neo-Flo, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012637</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DYL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:48.258Z</lastUpdated>
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  <row>
    <udiDi>00817441023440</udiDi>
    <basicUdiDi>081744102TF165J</basicUdiDi>
    <tradeName>Prime Dent Light Cure Dental Dam</tradeName>
    <deviceName>Alginate Flavoring</deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021-011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:28:10.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000529060</udiDi>
    <basicUdiDi>081000052BRUSHTIPEU</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Disposable Brush 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>S377</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:58.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000528285</udiDi>
    <basicUdiDi>081000052MIXINGTIP5K5</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 5</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>S535</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:57.615Z</lastUpdated>
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  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>H65890030491</udiDi>
    <basicUdiDi>03040412101AX</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Saliva ejectors</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9003049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:21:02.628Z</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>
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