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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 K231464
Device Name 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
3M Company, Unitek Orthodontic Products
2510 Conway Avenue
St. Paul,  MN  55144
Applicant Contact Brittany Randolph
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
Date Received05/19/2023
Decision Date 05/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No