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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 K211190
Device Name 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Applicant
3M Company, Unitek Orthodontic Products
2510 Conway Avenue
St. Paul,  MN  55144
Applicant Contact Yanine Garcia-Quezada
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
NXC  
Date Received04/21/2021
Decision Date 04/23/2021
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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