The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Atlantis Suprastructures.
Device ID | K163398 |
510k Number | K163398 |
Device Name: | ATLANTIS Suprastructures |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404 |
Contact | Karl Nittinger |
Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-05 |
Decision Date | 2017-08-14 |