The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Atlantis Abutment For Conelog Implant.
Device ID | K161030 |
510k Number | K161030 |
Device Name: | ATLANTIS Abutment For CONELOG Implant |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Dentsply Sirona 221 West Philadephia Street York, PA 17404 |
Contact | Helen Lewis |
Correspondent | Helen Lewis 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 | 2016-04-13 |
Decision Date | 2016-08-26 |
Summary: | summary |