ArgenIS Titanium Abutments— 510(k) K160248
Substantially EquivalentArgen Corporation
FDA 510(k) clearance K160248 for ArgenIS Titanium Abutments, Substantially Equivalent on 2016-08-05. Applicant: Argen Corporation. Device class: 2.
Clearance details
- Applicant
- Argen Corporation
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- San Diego, CA, US
Recent devices under product code NHA
view allMore clearances from Argen Corporation
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.