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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 K172765
Device Name Smart Moves Complete
Applicant
Great Lakes Orthodontics Ltd
200 Cooper Ave
Tonawanda,  NY  14150
Applicant Contact David Graver
Correspondent
Great Lakes Orthodontics Ltd
200 Cooper Ave
Tonawanda,  NY  14150
Correspondent Contact David Graver
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
DYW  
Date Received09/13/2017
Decision Date 06/01/2018
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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