3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)— 510(k) K211190
Substantially Equivalent3M Company, Unitek Orthodontic Products
FDA 510(k) clearance K211190 for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex), Substantially Equivalent on 2021-04-23. Applicant: 3M Company, Unitek Orthodontic Products. Device class: 2.
Clearance details
- Applicant
- 3M Company, Unitek Orthodontic Products
- Product code
- Code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Paul, MN, US
Recent devices under product code NXC
view allMore clearances from 3M Company, Unitek Orthodontic Products
view allAdverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.