The following data is part of a premarket notification filed by Zimmer Dental, Inc. with the FDA for Mri Compatibility For Existing Zimmer Dental Implant Systems.
| Device ID | K160398 |
| 510k Number | K160398 |
| Device Name: | MRI Compatibility For Existing Zimmer Dental Implant Systems |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Zimmer Dental, Inc. 1900 Aston Ave. Carlsbad, CA 92008 |
| Contact | Alex Eastes |
| Correspondent | Christina Boydston Zimmer Dental, Inc. 1900 Aston Ave. Carlsbad, CA 92008 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2017-05-17 |