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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 K232233
Device Name Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Applicant
Align Technology, Inc.
2820 Orchard Parkway
San Jose,  CA  95134
Applicant Contact John Ray
Correspondent
Align Technology, Inc.
2820 Orchard Parkway
San Jose,  CA  95134
Correspondent Contact John Ray
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/27/2023
Decision Date 09/26/2023
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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