ITI DENTAL IMPLANT SYSTEM
Implant, Endosseous, Root-form
STRAUMANN USA
The following data is part of a premarket notification filed by Straumann Usa with the FDA for Iti Dental Implant System.
Pre-market Notification Details
| Device ID | K012757 |
| 510k Number | K012757 |
| Device Name: | ITI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert STRAUMANN USA RESERVOIR PLACE, 1601 TRAPELO ROAD Waltham, MA 02154 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-08-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031719881 | K012757 | 000 |
| 07630031719300 | K012757 | 000 |
| 07630031719294 | K012757 | 000 |
| 07630031701107 | K012757 | 000 |
| 07630031701091 | K012757 | 000 |
| 07630031701084 | K012757 | 000 |
| 07630031701077 | K012757 | 000 |
| 07630031701060 | K012757 | 000 |
| 07630031701053 | K012757 | 000 |
| 07630031701046 | K012757 | 000 |
| 07630031719317 | K012757 | 000 |
| 07630031719492 | K012757 | 000 |
| 07630031719874 | K012757 | 000 |
| 07630031719867 | K012757 | 000 |
| 07630031719676 | K012757 | 000 |
| 07630031719669 | K012757 | 000 |
| 07630031719652 | K012757 | 000 |
| 07630031719645 | K012757 | 000 |
| 07630031719522 | K012757 | 000 |
| 07630031719515 | K012757 | 000 |
| 07630031719508 | K012757 | 000 |
| 07630031701039 | K012757 | 000 |
Trademark Results [ITI DENTAL IMPLANT SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ITI DENTAL IMPLANT SYSTEM 75614838 2454453 Dead/Cancelled |
Institut Straumann AG 1999-01-04 |
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