FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Argen Clear Aligner
K Number: K183229
·
Decision Jun 7, 2019
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
5
Review Days
199
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Basic Information
- Device Name
- Argen Clear Aligner
- K Number
- K183229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argen Corporation
- Date Received
- November 20, 2018
- Decision Date
- June 7, 2019
- 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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Other Clearances by Argen Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K242458 | ArgenZ MTZ | Oct 24, 2024 | Substantially Equivalent |
| K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | Feb 10, 2020 | Substantially Equivalent |
| K172430 | ArgenIS Titanium Abutments | May 18, 2018 | Substantially Equivalent |
| K160248 | ArgenIS Titanium Abutments | Aug 5, 2016 | Substantially Equivalent |