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    <tradeName>XP-endo Rise Retreatment</tradeName>
    <deviceName>Finisher</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.XB0.00.SAH.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:55.282Z</lastUpdated>
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    <udiDi>07640142435020</udiDi>
    <basicUdiDi>764014241050102A6</basicUdiDi>
    <tradeName>XP-endo Rise Shaper</tradeName>
    <deviceName>XP-4D STARTER</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.XB0.00.0AV.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:51.304Z</lastUpdated>
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    <udiDi>07640142420347</udiDi>
    <basicUdiDi>764014241080100B3</basicUdiDi>
    <tradeName>LENTULO</tradeName>
    <deviceName>LENTULO</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.171.21.025.GM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:50.492Z</lastUpdated>
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    <udiDi>07640142420156</udiDi>
    <basicUdiDi>764014241070100AQ</basicUdiDi>
    <tradeName>PLUGGERS</tradeName>
    <deviceName>PLUGGERS</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159012</emdnCode>
    <emdnDescription>ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02.110.21.015.CG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:49.677Z</lastUpdated>
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    <udiDi>07640142411154</udiDi>
    <basicUdiDi>7640142410401019R</basicUdiDi>
    <tradeName>D-RACE</tradeName>
    <deviceName>R-Motion</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.7B0.00.SAI.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:48.913Z</lastUpdated>
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    <udiDi>07640142410034</udiDi>
    <basicUdiDi>7640142410401029T</basicUdiDi>
    <tradeName>RACE</tradeName>
    <deviceName>BIORACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.0AF.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:30:44.907Z</lastUpdated>
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    <udiDi>07640142423799</udiDi>
    <basicUdiDi>7640142410201008Z</basicUdiDi>
    <tradeName>Endo Stand</tradeName>
    <deviceName>Endo Stand</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08.096.01.000.GR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:43.042Z</lastUpdated>
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    <udiDi>07640142423645</udiDi>
    <basicUdiDi>7640142410204009G</basicUdiDi>
    <tradeName>SMD Dispenser</tradeName>
    <deviceName>SMD Dispenser</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06.031.03.000.JA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:39.036Z</lastUpdated>
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    <udiDi>07640142423515</udiDi>
    <basicUdiDi>7640142410203009B</basicUdiDi>
    <tradeName>SMD</tradeName>
    <deviceName>SMD</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06.030.05.010.JA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:38.342Z</lastUpdated>
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    <udiDi>07640142423416</udiDi>
    <basicUdiDi>76401424102020096</basicUdiDi>
    <tradeName>Endo Stops</tradeName>
    <deviceName>Endo Stops</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06.010.00.010.RO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:22.985Z</lastUpdated>
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    <udiDi>07640142423096</udiDi>
    <basicUdiDi>7640142410205009M</basicUdiDi>
    <tradeName>Calcinable Pins</tradeName>
    <deviceName>Calcinable Pins</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05.300.00.052.TR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:22.181Z</lastUpdated>
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    <udiDi>07640142421986</udiDi>
    <basicUdiDi>7640142410101008N</basicUdiDi>
    <tradeName>Matrixes</tradeName>
    <deviceName>Matrixes</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.200.00.015.AC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:21.388Z</lastUpdated>
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    <udiDi>07640142421818</udiDi>
    <basicUdiDi>7640142410102008T</basicUdiDi>
    <tradeName>Matrix Band</tradeName>
    <deviceName>Matrix Band</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.059.01.503.AC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:20.585Z</lastUpdated>
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    <udiDi>07640142412953</udiDi>
    <basicUdiDi>7640142410301019E</basicUdiDi>
    <tradeName>K-FILES</tradeName>
    <deviceName>Barbed Broaches</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.1B4.00.SAJ.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:16.582Z</lastUpdated>
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    <udiDi>07640142412922</udiDi>
    <basicUdiDi>7640142410301029G</basicUdiDi>
    <tradeName>K-FILES</tradeName>
    <deviceName>Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.1B4.00.SAA.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:15.780Z</lastUpdated>
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    <udiDi>07640452462488</udiDi>
    <basicUdiDi>7640142410401019R</basicUdiDi>
    <tradeName>EDGETAPER PLATINUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETF121HTS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T19:41:34.867Z</lastUpdated>
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    <udiDi>07640142410010</udiDi>
    <basicUdiDi>B-07640142410010</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAA.FK</reference>
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    <lastUpdated>2026-06-16T05:54:56.290Z</lastUpdated>
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    <udiDi>07640142410027</udiDi>
    <basicUdiDi>B-07640142410027</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAB.FK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.272Z</lastUpdated>
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    <basicUdiDi>7640142410401029T</basicUdiDi>
    <tradeName>RACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.0AA.FK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.233Z</lastUpdated>
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    <basicUdiDi>7640142410401029T</basicUdiDi>
    <tradeName>RACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.0AB.FK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.215Z</lastUpdated>
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