<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810000525416</udiDi>
    <basicUdiDi>B-00810000525416</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:09.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525409</udiDi>
    <basicUdiDi>B-00810000525409</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:07.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525393</udiDi>
    <basicUdiDi>B-00810000525393</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:07.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525324</udiDi>
    <basicUdiDi>B-00810000525324</basicUdiDi>
    <tradeName>Retrieve™</tradeName>
    <deviceName>Retrieve</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:06.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525249</udiDi>
    <basicUdiDi>B-00810000525249</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>10ml Universal Shade HyperFIL® - DC (Dual-Cure)</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S326</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:05.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525232</udiDi>
    <basicUdiDi>B-00810000525232</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>10ml Enamel Shade HyperFIL® - DC (Dual-Cure)</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:04.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525065</udiDi>
    <basicUdiDi>B-00810000525065</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin®</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:14:00.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525034</udiDi>
    <basicUdiDi>B-00810000525034</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin®</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:59.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000525027</udiDi>
    <basicUdiDi>B-00810000525027</basicUdiDi>
    <tradeName>Absolute Dentin®</tradeName>
    <deviceName>Absolute Dentin</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:59.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522941</udiDi>
    <basicUdiDi>B-00810000522941</basicUdiDi>
    <tradeName>DuraTip®</tradeName>
    <deviceName>DuraTip® 30K Perio Right Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DURA30-PSR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:58.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522934</udiDi>
    <basicUdiDi>B-00810000522934</basicUdiDi>
    <tradeName>DuraTip®</tradeName>
    <deviceName>DuraTip® 30K Perio Left Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DURA30-PSL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:54.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522927</udiDi>
    <basicUdiDi>B-00810000522927</basicUdiDi>
    <tradeName>DuraTip®</tradeName>
    <deviceName>30K DuraTip® Universal Slim Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DURA30-US</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:53.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522903</udiDi>
    <basicUdiDi>B-00810000522903</basicUdiDi>
    <tradeName>DuraTip®</tradeName>
    <deviceName>30K DuraTip® Perio Slim Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DURA30-PS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:52.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522897</udiDi>
    <basicUdiDi>B-00810000522897</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Universal 30k Internal Water Scaler Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DUI30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:51.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522866</udiDi>
    <basicUdiDi>B-00810000522866</basicUdiDi>
    <tradeName>Burnett Power-Tip™</tradeName>
    <deviceName>25k Burnett Power-Tip™ Internal Water</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DTI25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:47.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522842</udiDi>
    <basicUdiDi>B-00810000522842</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Soft-Grip Universal 30k Internal Water Ultrasonic Scaler Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DSG30U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:46.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522835</udiDi>
    <basicUdiDi>B-00810000522835</basicUdiDi>
    <tradeName>Burnett Power-Tip™</tradeName>
    <deviceName>Soft-Grip 30k Burnett Power-Tip™ with Internal Water for Ultrasonic Scalers</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DSG30T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:31.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522811</udiDi>
    <basicUdiDi>B-00810000522811</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Soft-Grip Right Curved Perio Tip 30k Internal Water Ultrasonic Scaler Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DSG30R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:30.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522798</udiDi>
    <basicUdiDi>B-00810000522798</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Soft-Grip Perio 30k Internal Water Ultrasonic Scaler Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DSG30P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:30.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522767</udiDi>
    <basicUdiDi>B-00810000522767</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Soft-Grip Left Curved Perio Tip 30k Internal Water Ultrasonic Scaler Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DSG30L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:29.235Z</lastUpdated>
  </row>
</eudamedExport>