The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Mis Lance+ Conical Connection Dental Implant System.
Device ID | K210886 |
510k Number | K210886 |
Device Name: | MIS Lance+ Conical Connection Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
Contact | Karl J Nittinger |
Correspondent | Rebecca Sporer Dentsply Sirona 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 | 2021-03-25 |
Decision Date | 2021-06-17 |