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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 K220287
Device Name Invisalign System
Applicant
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact Shweta Daga
Correspondent
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact Shweta Daga
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/01/2022
Decision Date 04/07/2022
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
Recalls CDRH Recalls
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