The following data is part of a premarket notification filed by Straumann Usa Llc with the FDA for Mri Compatibility For Existing Straumann Dental Implant Systems.
| Device ID | K190662 |
| 510k Number | K190662 |
| Device Name: | MRI Compatibility For Existing Straumann Dental Implant Systems |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Straumann USA LLC 60 Minuteman Road Andover, MA 01810 |
| Contact | Loretta Kushner-mooney |
| Correspondent | Loretta Kushner-mooney Straumann USA LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZE |
| Subsequent Product Code | DZL |
| Subsequent Product Code | NHA |
| Subsequent Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-06-17 |