The following data is part of a premarket notification filed by Straumann Usa with the FDA for Iti Dental Implant System Monotype Implant.
| Device ID | K002374 |
| 510k Number | K002374 |
| Device Name: | ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-11-01 |