The following data is part of a premarket notification filed by Institut Straumann Sa with the FDA for Iti Dental Implant System.
Device ID | K003552 |
510k Number | K003552 |
Device Name: | ITI DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | INSTITUT STRAUMANN SA 60 MINUTEMAN ROAD Andover, MA 01810 |
Contact | Linda Jalbert |
Correspondent | Linda Jalbert INSTITUT STRAUMANN SA 60 MINUTEMAN ROAD Andover, MA 01810 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-17 |
Decision Date | 2001-08-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ITI DENTAL IMPLANT SYSTEM 75614838 2454453 Dead/Cancelled |
Institut Straumann AG 1999-01-04 |