The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Prosthetic Accessories To The Iti Dental Implant System.
| Device ID | K013798 |
| 510k Number | K013798 |
| Device Name: | PROSTHETIC ACCESSORIES TO THE 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 | 2001-11-15 |
| Decision Date | 2001-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725233 | K013798 | 000 |
| 07630031722263 | K013798 | 000 |
| 07630031722478 | K013798 | 000 |
| 07630031723673 | K013798 | 000 |
| 07630031723680 | K013798 | 000 |
| 07630031723765 | K013798 | 000 |
| 07630031723772 | K013798 | 000 |
| 07630031724458 | K013798 | 000 |
| 07630031725219 | K013798 | 000 |
| 07630031739261 | K013798 | 000 |