The following data is part of a premarket notification filed by Dentsply Sirona Inc. with the FDA for Mis Dental Implant System.
| Device ID | K192149 |
| 510k Number | K192149 |
| Device Name: | MIS Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Contact | Karl J. Nittinger |
| Correspondent | Karl J. Nittinger Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-12-11 |