The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Primetaper Ev Dental Implants Ø3.0, Ds Implants Abutments With Ev Connection (xs).
| Device ID | K220841 |
| 510k Number | K220841 |
| Device Name: | PrimeTaper EV Dental Implants Ø3.0, DS Implants Abutments With EV Connection (XS) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Courtney Clark |
| Correspondent | Courtney Clark 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 | 2022-03-23 |
| Decision Date | 2022-11-16 |