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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 K181739
Device Name Invisalign System with Mandibular Advancement Feature
Applicant
Align Technology, Inc.
2820 Orchard Pkwy
San Jose,  CA  95134
Applicant Contact Somi Ekwealor
Correspondent
Align Technology, Inc.
2820 Orchard Pkwy
San Jose,  CA  95134
Correspondent Contact Somi Ekwealor
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/02/2018
Decision Date 10/26/2018
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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