ITI DENTAL IMPLANT SYSTEM
Implant, Endosseous, Root-form
INSTITUT STRAUMANN AG
The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Iti Dental Implant System.
Pre-market Notification Details
| Device ID | K983742 |
| 510k Number | K983742 |
| Device Name: | ITI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-23 |
| Decision Date | 1999-03-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031719812 | K983742 | 000 |
| 07630031719157 | K983742 | 000 |
| 07630031719140 | K983742 | 000 |
| 07630031718860 | K983742 | 000 |
| 07630031718853 | K983742 | 000 |
| 07630031718846 | K983742 | 000 |
| 07630031718839 | K983742 | 000 |
| 07630031718624 | K983742 | 000 |
| 07630031718617 | K983742 | 000 |
| 07630031718600 | K983742 | 000 |
| 07630031718594 | K983742 | 000 |
| 07630031718587 | K983742 | 000 |
| 07630031718365 | K983742 | 000 |
| 07630031718358 | K983742 | 000 |
| 07630031718341 | K983742 | 000 |
| 07630031718334 | K983742 | 000 |
| 07630031719164 | K983742 | 000 |
| 07630031719409 | K983742 | 000 |
| 07630031719805 | K983742 | 000 |
| 07630031719799 | K983742 | 000 |
| 07630031719720 | K983742 | 000 |
| 07630031719713 | K983742 | 000 |
| 07630031719706 | K983742 | 000 |
| 07630031719690 | K983742 | 000 |
| 07630031719584 | K983742 | 000 |
| 07630031719577 | K983742 | 000 |
| 07630031719560 | K983742 | 000 |
| 07630031719553 | K983742 | 000 |
| 07630031719546 | K983742 | 000 |
| 07630031719447 | K983742 | 000 |
| 07630031719430 | K983742 | 000 |
| 07630031719423 | K983742 | 000 |
| 07630031719416 | K983742 | 000 |
| 07630031718327 | K983742 | 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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