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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 K180346
Device Name Byte Aligner System
Applicant
Straight Smile, LLC
528 Palisades Dr., #553
Pacific Palisades,  CA  90272
Applicant Contact Sepi Abbasi
Correspondent
Coombs Medical Device Consulting, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/08/2018
Decision Date 02/19/2019
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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