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    <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>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-340-011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:37.265Z</lastUpdated>
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  <row>
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    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
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    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
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    <reference>260-335-011</reference>
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    <tradeName>Integra-CP</tradeName>
    <deviceName>Integra-CP Implant</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-335-008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:30.335Z</lastUpdated>
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    <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>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-330-208</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:46:26.639Z</lastUpdated>
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    <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>
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    <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>
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    <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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    <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>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808002</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.966Z</lastUpdated>
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  <row>
    <udiDi>*+D99480800309*</udiDi>
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    <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>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808003</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.913Z</lastUpdated>
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  <row>
    <udiDi>*+D9948080040A*</udiDi>
    <basicUdiDi>B-*+D9948080040A*</basicUdiDi>
    <tradeName>DIVERGENT HEALER 3.3 MM H 6 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>808004</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.866Z</lastUpdated>
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  <row>
    <udiDi>*+D9948080050B*</udiDi>
    <basicUdiDi>B-*+D9948080050B*</basicUdiDi>
    <tradeName>DIVERGENT HEALER 4.1 MM HEIGHT 2 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>808005</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.815Z</lastUpdated>
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  <row>
    <udiDi>*+D9948080060C*</udiDi>
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    <tradeName>DIVERGENT HEALER 4.1 MM HEIGHT 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>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808006</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.742Z</lastUpdated>
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  <row>
    <udiDi>*+D9948080070D*</udiDi>
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    <tradeName>DIVERGENT HEALER 4.1 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>
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    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808007</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.711Z</lastUpdated>
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  <row>
    <udiDi>*+D9948080080E*</udiDi>
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    <tradeName>DIVERGENT HEALER 4.1 MM HEIGHT 5 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>808008</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.669Z</lastUpdated>
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    <udiDi>*+D9948080090F*</udiDi>
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    <tradeName>DIVERGENT HEALER 4.1 MM H 6 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.637Z</lastUpdated>
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    <udiDi>*+D99480801007*</udiDi>
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    <tradeName>DIVERGENT HEALER 5.0 MM HEIGHT 2 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.601Z</lastUpdated>
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    <tradeName>DIVERGENT HEALER 5.0 MM H 3 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:24.564Z</lastUpdated>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
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    <tradeName>DIVERGENT HEALER 5.0 MM H 6 MM HE</tradeName>
    <deviceName>Titanium component</deviceName>
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