FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K Number: K211190
·
Decision Apr 23, 2021
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
3
Review Days
2
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
- K Number
- K211190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Company, Unitek Orthodontic Products
- Date Received
- April 21, 2021
- Decision Date
- April 23, 2021
- Product Code
- NXC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NXC | Aligner, Sequential | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NXC), ordered by most recent decision date.
Smylio Aligners
FDA 510(k)
FDA Class 2
·Dental
SureSmile Aligner (ASSY500020)
FDA 510(k)
FDA Class 2
·Dental
ZSmile System
FDA 510(k)
FDA Class 2
·Dental
Clear Aligner (SCF-3348)
FDA 510(k)
FDA Class 2
·Dental
Primeprint Direct Aligner
FDA 510(k)
FDA Class 2
·Dental
Invisalign® Palatal Expander System
FDA 510(k)
FDA Class 2
·Dental