The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Dental Implants.
| Device ID | K061176 |
| 510k Number | K061176 |
| Device Name: | STRAUMANN DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-08-11 |
| Summary: | summary |