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    <manufacturerName>Ormco Corporation</manufacturerName>
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    <deviceName>Orthodontic Multi-Family Appliances</deviceName>
    <manufacturerName>RMO</manufacturerName>
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    <authorisedRepresentativeName>RMO EUROPE</authorisedRepresentativeName>
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    <reference>XPWHL35</reference>
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    <basicUdiDi>0883205-TF254BC</basicUdiDi>
    <tradeName>Gishy Goo</tradeName>
    <deviceName>Gishy Goo</deviceName>
    <manufacturerName>Ultradent Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013697</manufacturerSrn>
    <authorisedRepresentativeName>Ultradent Products GmbH</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
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    <reference>2749</reference>
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    <lastUpdated>2026-07-16T04:09:34.854Z</lastUpdated>
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    <basicUdiDi>08588130020200P4</basicUdiDi>
    <tradeName>Platypus</tradeName>
    <deviceName>Aligner Seating Chew</deviceName>
    <manufacturerName>Glenroe, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000056655</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
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    <reference>AC150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Oral Protector</tradeName>
    <deviceName>Reusable Oral Protector EMGD</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
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    <reference>EMGD</reference>
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    <tradeName>Gishy Goo</tradeName>
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    <manufacturerName>Ultradent Products, Inc.</manufacturerName>
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    <tradeName>Zendura</tradeName>
    <deviceName>Zendura TRAK</deviceName>
    <manufacturerName>Bay Materials LLC</manufacturerName>
    <manufacturerSrn>US-MF-000049150</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9308</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:57.833Z</lastUpdated>
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    <udiDi>00850016682147</udiDi>
    <basicUdiDi>08500166820003G7</basicUdiDi>
    <tradeName>Zendura</tradeName>
    <deviceName>Zendura FLX and Zendura VIVA</deviceName>
    <manufacturerName>Bay Materials LLC</manufacturerName>
    <manufacturerSrn>US-MF-000049150</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9204-20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:57.027Z</lastUpdated>
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    <basicUdiDi>08500166820002G5</basicUdiDi>
    <tradeName>Zendura</tradeName>
    <deviceName>Zendura AT</deviceName>
    <manufacturerName>Bay Materials LLC</manufacturerName>
    <manufacturerSrn>US-MF-000049150</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9206-20</reference>
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    <lastUpdated>2026-07-16T03:12:56.912Z</lastUpdated>
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    <tradeName>Zendura</tradeName>
    <deviceName>Zendura A</deviceName>
    <manufacturerName>Bay Materials LLC</manufacturerName>
    <manufacturerSrn>US-MF-000049150</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9156-20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:56.878Z</lastUpdated>
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    <udiDi>00850032808507</udiDi>
    <basicUdiDi>081744102TF085K</basicUdiDi>
    <tradeName>00850032808507</tradeName>
    <deviceName>Orthodontic Wax</deviceName>
    <manufacturerName>O&amp;S Dental, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023206</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>370-000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:28.418Z</lastUpdated>
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    <udiDi>00816063023777</udiDi>
    <basicUdiDi>081606302Specifix8W</basicUdiDi>
    <tradeName>Invisalign Specifix Attachment System</tradeName>
    <deviceName>Invisalign Specifix Attachment System</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036</reference>
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    <lastUpdated>2026-07-16T01:20:41.924Z</lastUpdated>
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    <udiDi>00816063021384</udiDi>
    <basicUdiDi>081606302IPESystem6S</basicUdiDi>
    <tradeName>Invisalign Palatal Holder</tradeName>
    <deviceName>Invisalign Palatal Expander System</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
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    <reference>9032</reference>
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    <lastUpdated>2026-07-16T01:20:05.992Z</lastUpdated>
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    <basicUdiDi>081606302CheekRetR8</basicUdiDi>
    <tradeName>Invisalign Cheek Retractor, Medium</tradeName>
    <deviceName>Invisalign Cheek Retractor, Medium</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
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    <basicUdiDi>081606302InvisalignMH</basicUdiDi>
    <tradeName>Invisalign Full</tradeName>
    <deviceName>Invisalign System</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
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    <lastUpdated>2026-07-16T01:19:51.602Z</lastUpdated>
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    <deviceName>Thermoplastic and Thermoforming material</deviceName>
    <manufacturerName>LEONE S.P.A.</manufacturerName>
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    <reference>A1730-01</reference>
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