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<eudamedExport entity="devices">
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    <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>
  </row>
  <row>
    <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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  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>D661US1025KOM0</udiDi>
    <basicUdiDi>B-D661US1025KOM0</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>D661US1025K0</udiDi>
    <basicUdiDi>B-D661US1025K0</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>D661US100R230UK0</udiDi>
    <basicUdiDi>B-D661US100R230UK0</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <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>
  </row>
  <row>
    <udiDi>D661US100R230CE0</udiDi>
    <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>
  </row>
  <row>
    <udiDi>D661US100030K0</udiDi>
    <basicUdiDi>B-D661US100030K0</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>D661US100025K0</udiDi>
    <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>
  </row>
  <row>
    <udiDi>08961101445522</udiDi>
    <basicUdiDi>B-08961101445522</basicUdiDi>
    <tradeName>08961101445522</tradeName>
    <deviceName>Excavator 1.5 mm</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-116</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:52:09.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961101445515</udiDi>
    <basicUdiDi>B-08961101445515</basicUdiDi>
    <tradeName>08961101445515</tradeName>
    <deviceName>Excavator 1 mm</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-115</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:52:08.768Z</lastUpdated>
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  <row>
    <udiDi>08961101445348</udiDi>
    <basicUdiDi>B-08961101445348</basicUdiDi>
    <tradeName>08961101445348</tradeName>
    <deviceName>Composite Instrument Condenser Freedman</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-17</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:51:43.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961101445331</udiDi>
    <basicUdiDi>B-08961101445331</basicUdiDi>
    <tradeName>08961101445331</tradeName>
    <deviceName>Composite Instrument Burnisher 1.2 mm- 1.6 mm</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-16</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:51:43.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961101445355</udiDi>
    <basicUdiDi>B-08961101445355</basicUdiDi>
    <tradeName>08961101445355</tradeName>
    <deviceName>Composite Instrument</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-18</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:51:41.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961101445324</udiDi>
    <basicUdiDi>B-08961101445324</basicUdiDi>
    <tradeName>08961101445324</tradeName>
    <deviceName>Composite Instrument Round Cone Shape</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-14</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:51:24.705Z</lastUpdated>
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    <udiDi>08961101445317</udiDi>
    <basicUdiDi>B-08961101445317</basicUdiDi>
    <tradeName>08961101445317</tradeName>
    <deviceName>Composite Instrument Westcott</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94-13</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:51:23.897Z</lastUpdated>
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    <udiDi>08961101443993</udiDi>
    <basicUdiDi>B-08961101443993</basicUdiDi>
    <tradeName>08961101443993</tradeName>
    <deviceName>Burnisher White No.  29/33 Hollow Handle D/E, SS</deviceName>
    <manufacturerName>Towne Brothers (Private) Limited</manufacturerName>
    <manufacturerSrn>PK-MF-000041737</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112-495-29/33-H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:47:54.810Z</lastUpdated>
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</eudamedExport>