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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 K183643
Device Name Clear Image Aligners
Applicant
Specialty Appliance Works, Inc.
4905 Hammond Industrial Drive
Cumming,  GA  30041
Applicant Contact Carolyn Thomas
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/26/2018
Decision Date 01/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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