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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 K183159
Device Name 3M Clarity Aligners
Applicant
3M Company
2510 Conway Ave.
Saint Paul,  MN  55144
Applicant Contact Yanine Garcia-Quezada
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/15/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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