The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Iti Transversal Screwing System.
| Device ID | K943720 |
| 510k Number | K943720 |
| Device Name: | ITI TRANSVERSAL SCREWING SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Contact | Carolyn Bitetti |
| Correspondent | Carolyn Bitetti THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-01 |
| Decision Date | 1995-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031726599 | K943720 | 000 |