FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULab Systems Dental Aligner Kit
K Number: K192596
·
Decision Feb 11, 2020
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
4
Review Days
144
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
- ULab Systems Dental Aligner Kit
- K Number
- K192596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulab Systems, Inc.
- Date Received
- September 20, 2019
- Decision Date
- February 11, 2020
- Product Code
- NXC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
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