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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caries Detector, Laser Light, Transmission
510(k) Number K240573
Device Name iTero Lumina™ Pro
Applicant
Align Technology , Ltd.
1 Yitzhak Rabin Rd.
Petach Tikva,  IL 4925110
Applicant Contact Aviva Touati
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact Kristin Zielinski Duggan
Regulation Number872.1745
Classification Product Code
NTK  
Subsequent Product Code
QJK  
Date Received03/01/2024
Decision Date 08/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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