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    <deviceName>BioSonic Ultrasonic Cleaners</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
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    <emdnCode>Z12011302</emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60021987</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:08:52.685Z</lastUpdated>
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    <udiDi>D661600139410</udiDi>
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    <tradeName>SPEC 3 LED USA Plug Type A</tradeName>
    <deviceName>LED Curing Lights</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
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    <emdnCode>Q01010199</emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60013941</reference>
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    <lastUpdated>2026-07-15T15:08:51.089Z</lastUpdated>
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    <tradeName>Ultrasonic Scaler Insert #10 (30kHz) – SLIM – SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:22.668Z</lastUpdated>
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    <udiDi>D661USG1030KOS0</udiDi>
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    <tradeName>Ultrasonic Scaler Insert #10 Slim OptiMist (30kHz) SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USG1030KOS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:21.859Z</lastUpdated>
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    <udiDi>D661USG1030K0</udiDi>
    <basicUdiDi>B-D661USG1030K0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 (30kHz) – SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USG1030K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:20.266Z</lastUpdated>
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    <udiDi>D661USG1025KSP0</udiDi>
    <basicUdiDi>B-D661USG1025KSP0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 (25kHz) – SLIM – SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:17.937Z</lastUpdated>
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    <udiDi>D661USG1025K0</udiDi>
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    <tradeName>Ultrasonic Scaler Insert #10 (25kHz) - SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USG1025K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:16.260Z</lastUpdated>
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    <udiDi>D661USG1025KOS0</udiDi>
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    <tradeName>Ultrasonic Scaler Insert #10 Slim OptiMist (25 kHz) SuperSoft</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USG1025KOS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:15.465Z</lastUpdated>
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    <udiDi>D661US1030KOS0</udiDi>
    <basicUdiDi>B-D661US1030KOS0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 Slim OptiMist (30kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1030KOS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:14.327Z</lastUpdated>
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    <udiDi>D661US1030KSP0</udiDi>
    <basicUdiDi>B-D661US1030KSP0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 (30kHz) - SLIM</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1030KSP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:00:11.585Z</lastUpdated>
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    <udiDi>D661US1030KOM0</udiDi>
    <basicUdiDi>B-D661US1030KOM0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert - #10 OptiMist (30kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1030KOM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:57.829Z</lastUpdated>
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    <udiDi>D661US1030K0</udiDi>
    <basicUdiDi>B-D661US1030K0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 (30kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1030K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:55.408Z</lastUpdated>
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    <udiDi>D661US1025KSP0</udiDi>
    <basicUdiDi>B-D661US1025KSP0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 (25kHz) - SLIM</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1025KSP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:53.807Z</lastUpdated>
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    <udiDi>D661US1025KOS0</udiDi>
    <basicUdiDi>B-D661US1025KOS0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #10 Slim OptiMist (25kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1025KOS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:53.039Z</lastUpdated>
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    <udiDi>D661US1025KOM0</udiDi>
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    <tradeName>Ultrasonic Scaler Insert - #10 OptiMist (25kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1025KOM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:51.416Z</lastUpdated>
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    <tradeName>Ultrasonic Scaler Insert, #10 Universal, 25 kHz</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US1025K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:49.000Z</lastUpdated>
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    <tradeName>BioSonic Ultrasonic Scaler UK</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US100R230UK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:47.431Z</lastUpdated>
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    <basicUdiDi>B-D661US100R230CE0</basicUdiDi>
    <tradeName>BioSonic Ultrasonic Scaler CE</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US100R230CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:46.625Z</lastUpdated>
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    <tradeName>Ultrasonic Scaler Insert #1000 Triple Bend (30kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US100030K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:45.000Z</lastUpdated>
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    <basicUdiDi>B-D661US100025K0</basicUdiDi>
    <tradeName>Ultrasonic Scaler Insert #1000 Triple Bend (25kHz)</tradeName>
    <deviceName>BioSonic US100R Ultrasonic Scaler</deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US100025K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:59:42.612Z</lastUpdated>
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