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).
Device ID | K211190 |
510k Number | K211190 |
Device Name: | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) |
Classification | Aligner, Sequential |
Applicant | 3M Company, Unitek Orthodontic Products 2510 Conway Avenue St. Paul, MN 55144 |
Contact | Yanine Garcia-quezada |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | NXC |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-04-21 |
Decision Date | 2021-04-23 |