K093113 is an FDA 510(k) clearance for the ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Institut Straumann AG (Graefelfing, Bavaria, DE). The FDA issued a Cleared decision on December 18, 2009, 78 days after receiving the submission on October 1, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K093113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2009 |
| Decision Date | December 18, 2009 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA — Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |