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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K252931
Device Name Invisalign® Palatal Expander System
Applicant
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact Ahanitha Ashok
Correspondent
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact Ahanitha Ashok
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received09/15/2025
Decision Date 10/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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