510(k) K211190
K211190 is an FDA 510(k) premarket notification submitted by 3M Company, Unitek Orthodontic Products for the device "3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)". The FDA issued a decision of Substantially Equivalent on Apr 23, 2021. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. 3M Company, Unitek Orthodontic Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2021
- Date Received
- Apr 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Aligner, Sequential
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.