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    <tradeName>On1 Clinical Screw 1.75 mm NP</tradeName>
    <deviceName>Multi-unit screws</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38744</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:12.693Z</lastUpdated>
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    <udiDi>07332747191820</udiDi>
    <basicUdiDi>73327470000002216U</basicUdiDi>
    <tradeName>On1 IOS Healing Cap 6 mm NP</tradeName>
    <deviceName>IOS Healing Abutments</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38734</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:11.896Z</lastUpdated>
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    <udiDi>07332747191769</udiDi>
    <basicUdiDi>733274700000017278</basicUdiDi>
    <tradeName>On1 Temporary Abutment Engaging NP</tradeName>
    <deviceName>Temporary prosthetic abutments</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38701</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:11.076Z</lastUpdated>
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    <udiDi>07332747190649</udiDi>
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    <tradeName>Trephine Drill 3.2/4.0mm</tradeName>
    <deviceName>Rescue instruments</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010501</emdnCode>
    <emdnDescription>DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37477</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:07.073Z</lastUpdated>
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    <udiDi>07332747190380</udiDi>
    <basicUdiDi>73327470000001316S</basicUdiDi>
    <tradeName>Cover Screw Conical Connection NP</tradeName>
    <deviceName>CC cover screws</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36649</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:06.288Z</lastUpdated>
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    <udiDi>07332747188608</udiDi>
    <basicUdiDi>73327470000001326U</basicUdiDi>
    <tradeName>Zygoma Implant Cover Screw</tradeName>
    <deviceName>Zygoma cover screws</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28989</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:05.480Z</lastUpdated>
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    <udiDi>07332747188578</udiDi>
    <basicUdiDi>73327470000001336W</basicUdiDi>
    <tradeName>Cover Screw Brånemark System® NP</tradeName>
    <deviceName>Straight &amp; machined cover screws</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28986</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:04.670Z</lastUpdated>
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    <udiDi>07332747187717</udiDi>
    <basicUdiDi>73327470000001577C</basicUdiDi>
    <tradeName>Guided Implant Mount NobelActive NP</tradeName>
    <deviceName>Guided implant placement tools</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35887</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:11:00.671Z</lastUpdated>
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    <udiDi>07332747185829</udiDi>
    <basicUdiDi>733274700000016275</basicUdiDi>
    <tradeName>IPS CaseDesigner 2.3 for Windows 64-bit</tradeName>
    <deviceName>Diagnostic and treatment software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300011_V2.3_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:59.883Z</lastUpdated>
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    <udiDi>07332747185553</udiDi>
    <basicUdiDi>733274700000014677</basicUdiDi>
    <tradeName>Guided Drill Tapered NP 3.5x(+)8mm</tradeName>
    <deviceName>Guided reusable drills for osteotomy</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32827</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:59.075Z</lastUpdated>
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    <udiDi>07332747181937</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Implant 3.6 for Win 64-bit</tradeName>
    <deviceName>Diagnostic and treatment software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300843_V3.6_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:58.297Z</lastUpdated>
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    <udiDi>07332747180756</udiDi>
    <basicUdiDi>73327470000002146X</basicUdiDi>
    <tradeName>DTX Studio Lab 1.12 for Windows 64-bit</tradeName>
    <deviceName>Design software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300607_V1.12_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:54.269Z</lastUpdated>
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    <udiDi>07332747178722</udiDi>
    <basicUdiDi>73327470000001957L</basicUdiDi>
    <tradeName>Guided Anchor Pin Sleeve Ø1.5mm 3/pkg</tradeName>
    <deviceName>Guided surgical template fixation</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30908</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:53.477Z</lastUpdated>
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    <udiDi>07332747177367</udiDi>
    <basicUdiDi>73327470000001757E</basicUdiDi>
    <tradeName>Implant Retrieval Instrument CC 3.0 31mm</tradeName>
    <deviceName>Retrieval instruments</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010501</emdnCode>
    <emdnDescription>DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37473</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:52.681Z</lastUpdated>
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    <udiDi>07332747176827</udiDi>
    <basicUdiDi>733274700000016377</basicUdiDi>
    <tradeName>Direction Indicator Nobel Biocare N1™</tradeName>
    <deviceName>Direction indicators</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159003</emdnCode>
    <emdnDescription>DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300918</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:51.864Z</lastUpdated>
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    <udiDi>07332747176780</udiDi>
    <basicUdiDi>73327470000001567A</basicUdiDi>
    <tradeName>Bone Mill Guide Nobel Biocare N1™ TCC NP Ø4.0</tradeName>
    <deviceName>Bone mill guide</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300911</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:47.874Z</lastUpdated>
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    <udiDi>07332747176421</udiDi>
    <basicUdiDi>73327470000001967N</basicUdiDi>
    <tradeName>Position Locator Single Abutment Nobel Biocare On1</tradeName>
    <deviceName>Lab position locators</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300437</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:47.072Z</lastUpdated>
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    <udiDi>07332747176360</udiDi>
    <basicUdiDi>733274700000020772</basicUdiDi>
    <tradeName>Try-in Screw Trefoil™ 3/pkg</tradeName>
    <deviceName>Trefoil lab tools for prosthetics</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300082</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:46.262Z</lastUpdated>
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    <udiDi>07332747176292</udiDi>
    <basicUdiDi>73327470000001787L</basicUdiDi>
    <tradeName>On1 Screwdriver Manual 25mm</tradeName>
    <deviceName>Screwdrivers Ir</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38753</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:45.455Z</lastUpdated>
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    <udiDi>07332747174540</udiDi>
    <basicUdiDi>733274700000020874</basicUdiDi>
    <tradeName>Guided Cylinder w Pin Unigrip Bmk Syst NP</tradeName>
    <deviceName>Lab tools for surgical templates</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32768</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:41.458Z</lastUpdated>
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