The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Atlantis Abutment For Mis Implant.
Device ID | K172225 |
510k Number | K172225 |
Device Name: | Atlantis Abutment For MIS Implant |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
Contact | Karl Nittinger |
Correspondent | Karl Nittinger Dentsply Sirona 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 | 2017-07-25 |
Decision Date | 2017-11-30 |
Summary: | summary |