<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800070232286</udiDi>
    <basicUdiDi>B-08800070232286</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6505W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232293</udiDi>
    <basicUdiDi>B-08800070232293</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6506W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232309</udiDi>
    <basicUdiDi>B-08800070232309</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6507W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232316</udiDi>
    <basicUdiDi>B-08800070232316</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6508W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232323</udiDi>
    <basicUdiDi>B-08800070232323</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6510W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232330</udiDi>
    <basicUdiDi>B-08800070232330</basicUdiDi>
    <tradeName>ZENEX Guide Twist Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGTD6511W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232347</udiDi>
    <basicUdiDi>B-08800070232347</basicUdiDi>
    <tradeName>ZENEX Guide Cortical Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGCDF50W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232354</udiDi>
    <basicUdiDi>B-08800070232354</basicUdiDi>
    <tradeName>ZENEX Guide Cortical Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGCDF60W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232361</udiDi>
    <basicUdiDi>B-08800070232361</basicUdiDi>
    <tradeName>ZENEX Guide Cortical Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZGCDF70W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232378</udiDi>
    <basicUdiDi>B-08800070232378</basicUdiDi>
    <tradeName>ZENEX Guide Wide Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZENGWKIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232385</udiDi>
    <basicUdiDi>B-08800070232385</basicUdiDi>
    <tradeName>ZENEX Guide Wide Kit(I-System)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZENGWSKIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232392</udiDi>
    <basicUdiDi>B-08800070232392</basicUdiDi>
    <tradeName>ZENEX Guide Wide Kit(T-System)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZENGWTKIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070232408</udiDi>
    <basicUdiDi>B-08800070232408</basicUdiDi>
    <tradeName>ZENEX Guide Wide Kit(R-System)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZENGWRKIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070235461</udiDi>
    <basicUdiDi>B-08800070235461</basicUdiDi>
    <tradeName>Taper Cortical Drill</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TACD4FF50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070246634</udiDi>
    <basicUdiDi>B-08800070246634</basicUdiDi>
    <tradeName>Abutment Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASRR21L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:43:50.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070206508</udiDi>
    <basicUdiDi>B-08800070206508</basicUdiDi>
    <tradeName>08800070206508</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T01:20:16.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070206775</udiDi>
    <basicUdiDi>B-08800070206775</basicUdiDi>
    <tradeName>08800070206775</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T01:20:09.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070206782</udiDi>
    <basicUdiDi>B-08800070206782</basicUdiDi>
    <tradeName>08800070206782</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T01:20:09.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070207529</udiDi>
    <basicUdiDi>B-08800070207529</basicUdiDi>
    <tradeName>08800070207529</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T01:20:09.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070209714</udiDi>
    <basicUdiDi>B-08800070209714</basicUdiDi>
    <tradeName>08800070209714</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Izenimplant Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000026205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-03T01:19:31.678Z</lastUpdated>
  </row>
</eudamedExport>