FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Argen Clear Aligner, Argen Clear Aligner Premium
K Number: K192846
·
Decision Feb 10, 2020
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
5
Review Days
130
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Basic Information
- Device Name
- Argen Clear Aligner, Argen Clear Aligner Premium
- K Number
- K192846
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argen Corporation
- Date Received
- October 3, 2019
- Decision Date
- February 10, 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 |
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