<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+E2995600300</udiDi>
    <basicUdiDi>++E299ROEKOPOLISHABRASIX6</basicUdiDi>
    <tradeName>Roeko Polishing Strip</tradeName>
    <deviceName>Roeko Polishing / Abrasive strip</deviceName>
    <manufacturerName>Polydentia SA</manufacturerName>
    <manufacturerSrn>CH-MF-000008779</manufacturerSrn>
    <authorisedRepresentativeName>IDD International Dental Distributors AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000008367</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>560030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:40:02.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E29955010</udiDi>
    <basicUdiDi>++E299DENTALABRASIVESGD</basicUdiDi>
    <tradeName>Polishing strip medium 40 µm</tradeName>
    <deviceName>DENTAL ABRASIVES</deviceName>
    <manufacturerName>Polydentia SA</manufacturerName>
    <manufacturerSrn>CH-MF-000008779</manufacturerSrn>
    <authorisedRepresentativeName>IDD International Dental Distributors AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000008367</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5501</reference>
    <placedOnMarketCountry>Liechtenstein</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:39:58.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E299041930</udiDi>
    <basicUdiDi>++E299INTERDENTABRASIVEB3</basicUdiDi>
    <tradeName>Abrasive and Polishing Strips</tradeName>
    <deviceName>Interdent / Abrasive and polishing strips</deviceName>
    <manufacturerName>Polydentia SA</manufacturerName>
    <manufacturerSrn>CH-MF-000008779</manufacturerSrn>
    <authorisedRepresentativeName>IDD International Dental Distributors AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000008367</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04193</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:39:07.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E2926240801</udiDi>
    <basicUdiDi>++E292dentalpolishersBA</basicUdiDi>
    <tradeName>Enhance Flex</tradeName>
    <deviceName>Finisher / Polisher</deviceName>
    <manufacturerName>EVE Ernst Vetter GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>624080</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:39:07.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>E217149401</udiDi>
    <basicUdiDi>++E217PROPHYPROTECTFE</basicUdiDi>
    <tradeName>ProphyProtect</tradeName>
    <deviceName>ProphyProtect Test Pack</deviceName>
    <manufacturerName>Kettenbach GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:31:01.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>14260614070551</udiDi>
    <basicUdiDi>++E165ROT1ROSS4001EM</basicUdiDi>
    <tradeName>roeko, 12 Steel Separating Strips, onesided, 4 mm, 50 µm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>570004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:28:28.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D959001250010</udiDi>
    <basicUdiDi>++D959DIAPOLPASKB</basicUdiDi>
    <tradeName>Intensiv UniglossPaste</tradeName>
    <deviceName>Intensiv UniglossPaste</deviceName>
    <manufacturerName>Intensiv SA</manufacturerName>
    <manufacturerSrn>CH-MF-000036274</manufacturerSrn>
    <authorisedRepresentativeName>Intensiv Trade GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000013123</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:18:31.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D932WP49131E</udiDi>
    <basicUdiDi>++D932PolPowUL</basicUdiDi>
    <tradeName>Vision Prophy Powder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent-A-Pharm Produktionsgesellschaft mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WP4913</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:18:03.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D932VI985011C</udiDi>
    <basicUdiDi>++D932PolPaLH</basicUdiDi>
    <tradeName>VIDU Prophy Paste</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent-A-Pharm Produktionsgesellschaft mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012922</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VI98501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:17:46.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>D779501CMN0</udiDi>
    <basicUdiDi>++D779STRIP101LM</basicUdiDi>
    <tradeName>D779501CMN0</tradeName>
    <deviceName>FlexiDiamond</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>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>501CMN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:11:06.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7794081010</udiDi>
    <basicUdiDi>++D779FeltFlexiPoint4R</basicUdiDi>
    <tradeName>D7794081010</tradeName>
    <deviceName></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>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>408101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:11:05.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D7794021010</udiDi>
    <basicUdiDi>++D779MANDREL101TU</basicUdiDi>
    <tradeName>D7794021010</tradeName>
    <deviceName>Mini Mandrel</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>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:11:02.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D779402000</udiDi>
    <basicUdiDi>++D779DISCBUFF101BV</basicUdiDi>
    <tradeName>D779402000</tradeName>
    <deviceName>Mini FlexiBuff</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>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:11:02.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746ORX000061</udiDi>
    <basicUdiDi>++D746SSDOCTORKITTA</basicUdiDi>
    <tradeName>SureSmile</tradeName>
    <deviceName>SureSmile Aligner Starter Kit (Doctor Kit)</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000000828</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORX00006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:12.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746530011</udiDi>
    <basicUdiDi>++D746STRIPCZ</basicUdiDi>
    <tradeName>N/A</tradeName>
    <deviceName>IPR Strips</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:07.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D74640035GRIP1</udiDi>
    <basicUdiDi>++D746GRIPFC</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName>SpaceFile (grip)</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40035-GRIP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:03.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>D746400341</udiDi>
    <basicUdiDi>++D746SFSTRIPDG</basicUdiDi>
    <tradeName>SpaceFile</tradeName>
    <deviceName>SpaceFile (files)</deviceName>
    <manufacturerName>Dentsply Sirona Orthodontics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:10:01.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D701SPARK2</udiDi>
    <basicUdiDi>++D701SPARK5U</basicUdiDi>
    <tradeName>Sparkle Diamond Polishing Paste</tradeName>
    <deviceName>Sparkle Diamond Polishing Paste</deviceName>
    <manufacturerName>Pulpdent Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004897</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPARK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:09:50.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D686200089403</udiDi>
    <basicUdiDi>++D68611168KJ</basicUdiDi>
    <tradeName>Waterpik Soft Shine Prophy Paste</tradeName>
    <deviceName>Dental Polishing Paste</deviceName>
    <manufacturerName>Water Pik, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017734</manufacturerSrn>
    <authorisedRepresentativeName>Sofibel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003191</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>20008940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:09:14.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>+D750LUCFLT0M</udiDi>
    <basicUdiDi>++D750FELTS3M</basicUdiDi>
    <tradeName>LUCIDA™ CLICK Felt [Refill]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VH Technologies Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000036198</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010403</emdnCode>
    <emdnDescription>DENTAL ABRASIVE AND POLISHING MATERIALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LUCFLT</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:08:17.398Z</lastUpdated>
  </row>
</eudamedExport>