The following data is part of a premarket notification filed by Dentsply Sirona Inc. with the FDA for Atlantis Suprastructures.
| Device ID | K193064 |
| 510k Number | K193064 |
| Device Name: | Atlantis Suprastructures |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2020-03-03 |