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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
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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