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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 K143630
Device Name Invisalign System
Applicant
ALIGN TECHNOLOGY, INC.
2560 Orchard Parkway
San Jose,  CA  95131
Applicant Contact Margaret Anderson
Correspondent
ALIGN TECHNOLOGY, INC.
2560 Orchard Parkway
San Jose,  CA  95131
Correspondent Contact Margaret Anderson
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/22/2014
Decision Date 11/18/2015
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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