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    <tradeName>Amazing Gracey™ 12-13 Rigid</tradeName>
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    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <lastUpdated>2026-06-16T20:38:10.419Z</lastUpdated>
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    <udiDi>00813677020413</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Amazing Gracey™ 11-12 Extended Reach</tradeName>
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    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
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    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Amazing Gracey™ 11-12 Extended Reach Rigid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <udiDi>00813677020437</udiDi>
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    <tradeName>Amazing Gracey™ 13-14 Extended Reach Rigid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R043R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.373Z</lastUpdated>
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    <udiDi>00813677020444</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Amazing Gracey™ 11-14 Extended Reach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.358Z</lastUpdated>
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    <udiDi>00813677020451</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Amazing Gracey™ 12-13 Extended Reach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.348Z</lastUpdated>
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    <udiDi>00813677020468</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Barnhart 1-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.336Z</lastUpdated>
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    <udiDi>00813677020475</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Barnhart 1-2 Rigid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R060R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.326Z</lastUpdated>
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    <udiDi>00813677020482</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Barnhart 5-6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.314Z</lastUpdated>
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    <udiDi>00813677020499</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Columbia 13-14</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R064</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.305Z</lastUpdated>
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    <udiDi>00813677020505</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Columbia 2L-2R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R066</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.296Z</lastUpdated>
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    <udiDi>00813677020512</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Columbia 4L-4R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R067</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.285Z</lastUpdated>
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    <udiDi>00813677020529</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>McCalls 13-14</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R069</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.267Z</lastUpdated>
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    <udiDi>00813677020536</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>McCalls 13S-14S (Sharp)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.256Z</lastUpdated>
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    <udiDi>00813677020543</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>McCalls 17S-18S (Slim)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.244Z</lastUpdated>
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    <udiDi>00813677020550</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
    <tradeName>Rules 3-4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R076</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.235Z</lastUpdated>
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    <udiDi>00813677020567</udiDi>
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    <tradeName>Younger-Good 7-8</tradeName>
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    <manufacturerName>PDT, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R077</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.218Z</lastUpdated>
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    <udiDi>00813677020574</udiDi>
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    <manufacturerName>PDT, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R079</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00813677020581</udiDi>
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    <manufacturerName>PDT, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00813677020598</udiDi>
    <basicUdiDi>0813677021801WC</basicUdiDi>
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    <manufacturerName>PDT, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045324</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R081</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:38:10.170Z</lastUpdated>
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