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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K262196
Device Name Invisalign System
Applicant
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact Sindhura Gaddamanugu
Correspondent
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact Sindhura Gaddamanugu
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
NXC  
Date Received06/29/2026
Decision Date 09/25/2026
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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