The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Etkon Es1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment.
| Device ID | K093113 |
| 510k Number | K093113 |
| Device Name: | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG LOCHHAMER SCHLAG 6 Graefelfing, Bavaria, DE 82166 |
| Contact | Andreas Petermann |
| Correspondent | Andreas Petermann INSTITUT STRAUMANN AG LOCHHAMER SCHLAG 6 Graefelfing, Bavaria, DE 82166 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2009-12-18 |
| Summary: | summary |