# K213449: DS Implants abutments provided with the EV connection

- Pathway: 510(k) (Special)
- Applicant: Dentsply Sirona
- Decided: Nov 15, 2021 after 20 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894595 (1990). 237 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 6.
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures, Dentsply Sirona (2017) Summary page 6.

## Most influential descendants
- K220841: PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (2022), 0 descendants of its own
- K221094: OmniTaper EV Dental Implants, DS Implants abutments with EV connection (2022), 0 descendants of its own

## Indications for use
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

Source page: https://510kreport.com/device/K213449
Methodology: https://510kreport.com/methodology