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    <deviceName>Mixing Tip 3</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S439IOT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:51.196Z</lastUpdated>
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    <udiDi>10810000526960</udiDi>
    <basicUdiDi>081000052NEEDLETIP4ZK</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Application Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
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    <udiDi>10810000526861</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing/Dispensing Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:47.203Z</lastUpdated>
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    <basicUdiDi>081000052MIXINGTIP4K3</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 4</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:45.592Z</lastUpdated>
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    <udiDi>10810000526847</udiDi>
    <basicUdiDi>081000052MIXINGTIP2JX</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Mixing Tip 2</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:44.791Z</lastUpdated>
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    <udiDi>10810000526830</udiDi>
    <basicUdiDi>081000052NEEDLETIP2ZF</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Pre-Bent Needle Tip</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:43.190Z</lastUpdated>
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    <udiDi>10810000526809</udiDi>
    <basicUdiDi>081000052NEEDLETIP3ZH</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Luer Lock Applicator Tips</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:33:40.788Z</lastUpdated>
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    <udiDi>H65890030491</udiDi>
    <basicUdiDi>03040412101AX</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Saliva ejectors</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9003049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:21:02.628Z</lastUpdated>
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    <udiDi>10304040132217</udiDi>
    <basicUdiDi>03040444801DH</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Microtip applicators</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5702048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:20:21.361Z</lastUpdated>
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    <udiDi>10304040090982</udiDi>
    <basicUdiDi>03040417001BV</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Dental Dam Natural Rubber Latex</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002650</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:19:57.281Z</lastUpdated>
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    <udiDi>10304040082024</udiDi>
    <basicUdiDi>03040437201CV</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Non Latex Dental Dam</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019002</emdnCode>
    <emdnDescription>DENTISTRY DAMS AND HOOKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5701622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:19:49.363Z</lastUpdated>
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    <udiDi>10302732311025</udiDi>
    <basicUdiDi>03027360408D530780QJCSZ</basicUdiDi>
    <tradeName>Trace disclosing solution 2oz.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Young Dental Manufacturing I, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027132</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019003</emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>231102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:19:24.113Z</lastUpdated>
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    <udiDi>03700425932494</udiDi>
    <basicUdiDi>03700425NS-classI-004W7</basicUdiDi>
    <tradeName>Cotons salivaires N°3 -Pasteur /40x150</tradeName>
    <deviceName>Dentaire</deviceName>
    <manufacturerName>MEDISTOCK</manufacturerName>
    <manufacturerSrn>FR-MF-000007667</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019004</emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H8003P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:15:31.726Z</lastUpdated>
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    <udiDi>03700425908819</udiDi>
    <basicUdiDi>03700425NS-classI-007WD</basicUdiDi>
    <tradeName>Micros applicateurs standard vert /4800</tradeName>
    <deviceName>Embout</deviceName>
    <manufacturerName>MEDISTOCK</manufacturerName>
    <manufacturerSrn>FR-MF-000007667</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K50031G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:15:07.855Z</lastUpdated>
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    <udiDi>00860004740322</udiDi>
    <basicUdiDi>03629421035002GA</basicUdiDi>
    <tradeName>HybenX® OTD Gel</tradeName>
    <deviceName>HYBENX OTD Gel</deviceName>
    <manufacturerName>EPIEN Medical, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008278</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019007</emdnCode>
    <emdnDescription>BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-5002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:14:29.275Z</lastUpdated>
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    <udiDi>00860004740315</udiDi>
    <basicUdiDi>03629421032001FK</basicUdiDi>
    <tradeName>HybenX® OTD</tradeName>
    <deviceName>HybenX®  OTD</deviceName>
    <manufacturerName>EPIEN Medical, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008278</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-2001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:14:23.242Z</lastUpdated>
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    <udiDi>00362942000020</udiDi>
    <basicUdiDi>03629421050003FX</basicUdiDi>
    <tradeName>00362942000020</tradeName>
    <deviceName>Oralmedic</deviceName>
    <manufacturerName>EPIEN Medical, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008278</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
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    <emdnDescription>BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:14:06.361Z</lastUpdated>
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    <udiDi>00310866000121</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Oratip Adapter</tradeName>
    <deviceName>Miscellaneous Class I Dental Accessories</deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24080</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:13:20.586Z</lastUpdated>
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    <basicUdiDi>03040410901BR</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Cotton Rolls and Pellets</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019004</emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001895</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:12:50.677Z</lastUpdated>
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    <udiDi>00304040053881</udiDi>
    <basicUdiDi>03040442401CF</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Oral hygiene products</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019003</emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9883134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:12:44.950Z</lastUpdated>
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