3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Aligner, Sequential

3M Company, Unitek Orthodontic Products

The following data is part of a premarket notification filed by 3m Company, Unitek Orthodontic Products with the FDA for 3m Clarity Aligners (3m Clarity Aligners-force, 3m Clarity Aligners-flex).

Pre-market Notification Details

Device IDK211190
510k NumberK211190
Device Name:3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
ClassificationAligner, Sequential
Applicant 3M Company, Unitek Orthodontic Products 2510 Conway Avenue St. Paul,  MN  55144
ContactYanine Garcia-quezada
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-04-21
Decision Date2021-04-23

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