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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Transmission Caries Detector
510(k) Number K261847
Device Name iTero Lumina™ Pro
Applicant
Align Technology , Ltd.
1 Yitzhak Rabin Rd.
Petach Tikva,  IL 4925110
Applicant Contact Aviva Touati
Correspondent
Align Technology , Ltd.
1 Yitzhak Rabin Rd.
Petach Tikva,  IL 4925110
Correspondent Contact Aviva Touati
Regulation Number872.1745
Classification Product Code
NTK  
Date Received06/03/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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