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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-240-545</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:42:06.505Z</lastUpdated>
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    <tradeName>Temporary</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
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    <reference>260-240-525</reference>
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    <tradeName>Temporary</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
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    <tradeName>Non-Shouldered</tradeName>
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    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:58.090Z</lastUpdated>
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    <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>
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    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-240-101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:57.290Z</lastUpdated>
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    <udiDi>00813110021410</udiDi>
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    <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>
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    <legislation>MDD</legislation>
    <emdnCode>P010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-240-025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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  <row>
    <udiDi>00813110021403</udiDi>
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    <tradeName>Non-Shouldered</tradeName>
    <deviceName>Dental Abutment</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-240-015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:55.700Z</lastUpdated>
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    <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>
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    <emdnDescription>ODONTOLOGICAL PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-240-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:51.690Z</lastUpdated>
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    <udiDi>00813110021328</udiDi>
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    <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>260-200-242</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:50.882Z</lastUpdated>
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    <udiDi>00813110021298</udiDi>
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    <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>260-200-221</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:50.092Z</lastUpdated>
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  <row>
    <udiDi>00813110021304</udiDi>
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    <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>260-200-222</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:49.299Z</lastUpdated>
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  <row>
    <udiDi>*+D99480800107*</udiDi>
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    <tradeName>DIVERGENT HEALER 3.3 MM H 3 MM HE</tradeName>
    <deviceName>Titanium Component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:25.005Z</lastUpdated>
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  <row>
    <udiDi>*+D99480800208*</udiDi>
    <basicUdiDi>B-*+D99480800208*</basicUdiDi>
    <tradeName>DIVERGENT HEALER 3.3 MM H 4 MM HE</tradeName>
    <deviceName>Titanium Component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808002</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480800309*</udiDi>
    <basicUdiDi>B-*+D99480800309*</basicUdiDi>
    <tradeName>DIVERGENT HEALER 3.3 MM H 5 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
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    <reference>808003</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.913Z</lastUpdated>
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  <row>
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    <tradeName>DIVERGENT HEALER 3.3 MM H 6 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.866Z</lastUpdated>
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    <udiDi>*+D9948080050B*</udiDi>
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    <tradeName>DIVERGENT HEALER 4.1 MM HEIGHT 2 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.815Z</lastUpdated>
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    <tradeName>DIVERGENT HEALER 4.1 MM HEIGHT 3 MM HE</tradeName>
    <deviceName>Titanium Component</deviceName>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.742Z</lastUpdated>
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