ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT— 510(k) K093113
Substantially EquivalentInstitut Straumann AG
FDA 510(k) clearance K093113 for ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT, Substantially Equivalent on 2009-12-18. Applicant: Institut Straumann AG. Device class: 2.
Clearance details
- Applicant
- Institut Straumann AG
- 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
- Traditional
- Location
- Graefelfing, Bavaria, DE
Recent devices under product code NHA
view allMore clearances from Institut Straumann AG
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.