The following data is part of a premarket notification filed by Straumann Usa with the FDA for Abutment And Prosthetic Accessories To The Iti Dental Implant System.
| Device ID | K022859 |
| 510k Number | K022859 |
| Device Name: | ABUTMENT AND PROSTHETIC ACCESSORIES TO THE 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 | 2002-08-28 |
| Decision Date | 2002-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725455 | K022859 | 000 |
| 07630031725448 | K022859 | 000 |
| 07630031725424 | K022859 | 000 |
| 07630031725400 | K022859 | 000 |
| 07630031725394 | K022859 | 000 |
| 07630031725202 | K022859 | 000 |
| 07630031723741 | K022859 | 000 |
| 07630031717276 | K022859 | 000 |
| 07630031717269 | K022859 | 000 |