FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ArgenIS Titanium Abutments
K Number: K143051
·
Decision Sep 16, 2015
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
6
Review Days
328
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
- ArgenIS Titanium Abutments
- K Number
- K143051
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Argen Corporation
- Date Received
- October 23, 2014
- Decision Date
- September 16, 2015
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by The Argen Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K190079 | ArgenZ HT+ | Apr 12, 2019 | Substantially Equivalent |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | Feb 8, 2019 | Substantially Equivalent |
| K150919 | ArgenZ Esthetic Plus | Jul 13, 2015 | Substantially Equivalent |
| K140894 | ARGEN PMMA | Jul 31, 2014 | Substantially Equivalent |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | Aug 15, 2007 | Substantially Equivalent |