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<eudamedExport entity="devices">
  <row>
    <udiDi>08800053004701</udiDi>
    <basicUdiDi>88061691DENTIS-I7L</basicUdiDi>
    <tradeName>Simple Guide Plus Sleeve Connector</tradeName>
    <deviceName>DENTIS Implant Surgical Instrument System</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSGPSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:40.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800313232035</udiDi>
    <basicUdiDi>88000530LC9N</basicUdiDi>
    <tradeName>Luvis Chair</tradeName>
    <deviceName>Luvis Chair</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110101</emdnCode>
    <emdnDescription>DENTAL TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC700C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:48.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800266945068</udiDi>
    <basicUdiDi>88000530E100BR</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Luminaire for diagnosis</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:47.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800266944375</udiDi>
    <basicUdiDi>88000530C500BX</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Dental Light</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:46.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053099301</udiDi>
    <basicUdiDi>88000530LM400B7</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:19.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053095952</udiDi>
    <basicUdiDi>88000530M300DT</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:17.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053094351</udiDi>
    <basicUdiDi>88000530LM200AV</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:15.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093767</udiDi>
    <basicUdiDi>88000530S300F5</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:14.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093644</udiDi>
    <basicUdiDi>88000530S250FF</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSM-V4-202510-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:13.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053093460</udiDi>
    <basicUdiDi>88000530S200EY</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Surgical Luminaire</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:10.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053091305</udiDi>
    <basicUdiDi>88000530DC1RZ</basicUdiDi>
    <tradeName>Luvis Chair</tradeName>
    <deviceName>Luvis Chair</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110101</emdnCode>
    <emdnDescription>DENTAL TREATMENT UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC700C-chair only</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:09.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053091237</udiDi>
    <basicUdiDi>88000530STBD</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Operating Table</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVST-V3-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:08.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053084123</udiDi>
    <basicUdiDi>88000530DISAKB</basicUdiDi>
    <tradeName>ChecQ</tradeName>
    <deviceName>ChecQ</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:06.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053082655</udiDi>
    <basicUdiDi>88000530AISU6</basicUdiDi>
    <tradeName>DENOPS-i</tradeName>
    <deviceName>DENOPS-i</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020203</emdnCode>
    <emdnDescription>CARTRIDGE SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:02.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800053045049</udiDi>
    <basicUdiDi>88000530C600C4</basicUdiDi>
    <tradeName>LUVIS</tradeName>
    <deviceName>Dental Light</deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-C-LVSL-V5-202602-ENG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:02.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806169100818</udiDi>
    <basicUdiDi>B-08806169100818</basicUdiDi>
    <tradeName>s-Clean Tapered Fixture</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSFM3708</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:44.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806169100825</udiDi>
    <basicUdiDi>B-08806169100825</basicUdiDi>
    <tradeName>s-Clean Tapered Fixture</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSFM3710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:44.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806169103857</udiDi>
    <basicUdiDi>88061691DENTIS-I7L</basicUdiDi>
    <tradeName>s-Clean Plastic UCLA Abutment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEPMH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:44.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806169103864</udiDi>
    <basicUdiDi>88061691DENTIS-I7L</basicUdiDi>
    <tradeName>s-Clean Plastic UCLA Abutment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEPMN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:44.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806169103871</udiDi>
    <basicUdiDi>88061691DENTIS-I7L</basicUdiDi>
    <tradeName>s-Clean Plastic UCLA Abutment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTIS CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000012523</manufacturerSrn>
    <authorisedRepresentativeName>BEST FIT IMPLANTS S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048728</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEPRH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:44.051Z</lastUpdated>
  </row>
</eudamedExport>