<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813110022547</udiDi>
    <basicUdiDi>B-00813110022547</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-340-011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:37.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022530</udiDi>
    <basicUdiDi>B-00813110022530</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-340-008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:32.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022523</udiDi>
    <basicUdiDi>B-00813110022523</basicUdiDi>
    <tradeName>Non-Shouldered</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-340-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:31.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022516</udiDi>
    <basicUdiDi>B-00813110022516</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-335-011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:31.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022509</udiDi>
    <basicUdiDi>B-00813110022509</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-335-008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:30.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022493</udiDi>
    <basicUdiDi>B-00813110022493</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-330-208</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:26.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022486</udiDi>
    <basicUdiDi>B-00813110022486</basicUdiDi>
    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-330-206</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:25.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022462</udiDi>
    <basicUdiDi>B-00813110022462</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-622</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:23.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022455</udiDi>
    <basicUdiDi>B-00813110022455</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-621</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:23.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022448</udiDi>
    <basicUdiDi>B-00813110022448</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-602</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:18.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022431</udiDi>
    <basicUdiDi>B-00813110022431</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-601</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:17.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022370</udiDi>
    <basicUdiDi>B-00813110022370</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-439</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:16.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022363</udiDi>
    <basicUdiDi>B-00813110022363</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-438</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:16.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022356</udiDi>
    <basicUdiDi>B-00813110022356</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-437</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:11.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022349</udiDi>
    <basicUdiDi>B-00813110022349</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-436</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:11.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022332</udiDi>
    <basicUdiDi>B-00813110022332</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-435</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:10.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022325</udiDi>
    <basicUdiDi>B-00813110022325</basicUdiDi>
    <tradeName>Brevis</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-434</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:09.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022318</udiDi>
    <basicUdiDi>B-00813110022318</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-400</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:44:07.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022301</udiDi>
    <basicUdiDi>B-00813110022301</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-361</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:44:07.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813110022295</udiDi>
    <basicUdiDi>B-00813110022295</basicUdiDi>
    <tradeName>Stealth</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-300-342</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:44:06.109Z</lastUpdated>
  </row>
</eudamedExport>