The following data is part of a premarket notification filed by Institut Straumann Sa with the FDA for Iti Dental Implant System.
| Device ID | K003552 |
| 510k Number | K003552 |
| Device Name: | ITI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN SA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert INSTITUT STRAUMANN SA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-08-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ITI DENTAL IMPLANT SYSTEM 75614838 2454453 Dead/Cancelled |
Institut Straumann AG 1999-01-04 |