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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 K232887
Device Name Invisalign Palatal Expander System
Applicant
Align Technology, Inc.
2820 Orchard Parkway
San Jose,  CA  95134
Applicant Contact Sindhura Gaddamanugu
Correspondent
Align Technology, Inc.
2820 Orchard Parkway
San Jose,  CA  95134
Correspondent Contact Sindhura Gaddamanugu
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received09/18/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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