The following data is part of a premarket notification filed by Dentsply Sirona, Inc. with the FDA for Primetaper Ev Dental Implant.
| Device ID | K210610 |
| 510k Number | K210610 |
| Device Name: | PrimeTaper EV Dental Implant |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentsply Sirona, Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl J Nittinger |
| Correspondent | Rebecca Sporer Dentsply Sirona, Inc. 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 | 2021-03-01 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07392532258855 | K210610 | 000 |
| 07392532258718 | K210610 | 000 |
| 07392532258701 | K210610 | 000 |
| 07392532258695 | K210610 | 000 |
| 07392532258688 | K210610 | 000 |
| 07392532258671 | K210610 | 000 |
| 07392532258664 | K210610 | 000 |
| 07392532258657 | K210610 | 000 |
| 07392532258640 | K210610 | 000 |
| 07392532258633 | K210610 | 000 |
| 07392532258626 | K210610 | 000 |
| 07392532258619 | K210610 | 000 |
| 07392532258725 | K210610 | 000 |
| 07392532258732 | K210610 | 000 |
| 07392532258848 | K210610 | 000 |
| 07392532258831 | K210610 | 000 |
| 07392532258824 | K210610 | 000 |
| 07392532258817 | K210610 | 000 |
| 07392532258800 | K210610 | 000 |
| 07392532258794 | K210610 | 000 |
| 07392532258787 | K210610 | 000 |
| 07392532258770 | K210610 | 000 |
| 07392532258763 | K210610 | 000 |
| 07392532258756 | K210610 | 000 |
| 07392532258749 | K210610 | 000 |
| 07392532258602 | K210610 | 000 |