The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Modification To Iti Dental Implant System.
| Device ID | K003271 |
| 510k Number | K003271 |
| Device Name: | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG RESERVOIR PLACE 1601 TRAPELO ROAD Waltham, MA 02451 |
| Contact | Carolyn Bitetti |
| Correspondent | Carolyn Bitetti 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 | 2000-10-18 |
| Decision Date | 2001-03-20 |