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    <tradeName>Guided Drill 4.6 x 8mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG4608</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.375Z</lastUpdated>
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    <udiDi>00815131029437</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 4.6 x 10mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG4610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.351Z</lastUpdated>
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    <udiDi>00815131029444</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 4.6 x 11.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG4611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.328Z</lastUpdated>
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    <udiDi>00815131029451</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 4.6 x 13mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG4613</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.307Z</lastUpdated>
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    <udiDi>00815131029468</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Flat Milling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILGFLAT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.287Z</lastUpdated>
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    <udiDi>00815131029475</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Starter 3.6x2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.274Z</lastUpdated>
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    <udiDi>00815131029482</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 3mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.254Z</lastUpdated>
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  <row>
    <udiDi>00815131029499</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3604</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.232Z</lastUpdated>
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  <row>
    <udiDi>00815131029505</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3605</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.213Z</lastUpdated>
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  <row>
    <udiDi>00815131029512</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 6mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3606</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.195Z</lastUpdated>
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  <row>
    <udiDi>00815131029529</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 7mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3607</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:35.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029536</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 8mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3608</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:35.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029543</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 9mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3609</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:35.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029550</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 10mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:35.094Z</lastUpdated>
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  <row>
    <udiDi>00815131029567</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill Guided Sinus Lift 3.6 x 11mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG-SD3611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:35.074Z</lastUpdated>
  </row>
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    <udiDi>00815131029574</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill N Implant 4.1 Long</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILL3630L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00815131029581</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill N Implant 4.1 Short</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILL3630S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00815131029598</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill N Implant 4.7 Long</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILL4438L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00815131029604</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill N Implant 4.7 Short</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILL4438S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:34.978Z</lastUpdated>
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    <udiDi>00815131029611</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Drill N Implant 7.0 Short</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILL6653S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:34.957Z</lastUpdated>
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