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    <tradeName>iTero Element 5D Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.735Z</lastUpdated>
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    <udiDi>00816063022565</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Laptop Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.716Z</lastUpdated>
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    <udiDi>00816063022596</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Plus mobile configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.696Z</lastUpdated>
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    <udiDi>00816063022671</udiDi>
    <basicUdiDi>081606302IOCPRO5A</basicUdiDi>
    <tradeName>iTero Lumina Pro Scanning Unit, RMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.674Z</lastUpdated>
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    <udiDi>00816063022831</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Cart Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.571Z</lastUpdated>
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    <udiDi>00816063022848</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Mobile Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221962</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.553Z</lastUpdated>
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    <udiDi>00816063022893</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Mobile Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>224166</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.507Z</lastUpdated>
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    <udiDi>00816063022916</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Scanning Unit Lumina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222984</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.497Z</lastUpdated>
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    <udiDi>00816063022954</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Scanning Unit RMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>216498</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.480Z</lastUpdated>
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    <udiDi>00816063022961</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Scanning Unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223169</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.456Z</lastUpdated>
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    <udiDi>00816063023012</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element™ 5D imaging system, Certified Pre-owned</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217617</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.436Z</lastUpdated>
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    <udiDi>00816063023050</udiDi>
    <basicUdiDi>081606302LMNSCNUEV</basicUdiDi>
    <tradeName>iTero Lumina - PC cfg  intraoral scanning unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.417Z</lastUpdated>
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    <udiDi>00816063023067</udiDi>
    <basicUdiDi>081606302SWPROAL</basicUdiDi>
    <tradeName>iTero Lumina Pro Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225979</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.401Z</lastUpdated>
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    <udiDi>00816063023166</udiDi>
    <basicUdiDi>081606302LMNIFB57</basicUdiDi>
    <tradeName>iTero Lumina Interface Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.361Z</lastUpdated>
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    <udiDi>00816063023173</udiDi>
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    <tradeName>00816063023173</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217622</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.347Z</lastUpdated>
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    <udiDi>00816063023197</udiDi>
    <basicUdiDi>081606302LMNSW6A</basicUdiDi>
    <tradeName>iTero Lumina Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225969</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.309Z</lastUpdated>
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    <udiDi>00816063023210</udiDi>
    <basicUdiDi>081606302LMNSCNUEV</basicUdiDi>
    <tradeName>iTero Lumina - PC cfg  intraoral scanning unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.267Z</lastUpdated>
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    <udiDi>00816063023258</udiDi>
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    <tradeName>iTero Lumina PC cfg Scanning Unit, RMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.200Z</lastUpdated>
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    <basicUdiDi>081606302LMNSCNUEV</basicUdiDi>
    <tradeName>iTero Lumina PC cfg Scanning Unit, RMA Package</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00816063023272</udiDi>
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    <tradeName>iTero Lumina PC cfg Scanning Unit, RMA Package</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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