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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 K171674
Device Name Angel Align System
Applicant
Smile Development Corp
7179 Cherrywood Ct.
Highland,  CA  92346
Applicant Contact Ian Kitching
Correspondent
Smile Development Corp
7179 Cherrywood Ct.
Highland,  CA  92346
Correspondent Contact Ian Kitching
Regulation Number872.5470
Classification Product Code
NXC  
Date Received06/06/2017
Decision Date 01/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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