# K221094: OmniTaper EV Dental Implants, DS Implants abutments with EV connection

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Nov 16, 2022 after 216 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K894595 (1990). 238 ancestors in all.
No later device cites it as a predicate yet.
0 of 239 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.
- K213449: DS Implants abutments provided with the EV connection, Dentsply Sirona (2021) Summary page 6.

## Indications for use
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: • Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. • Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. • Especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. • Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate. • The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors. 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. MultiBase Abutments EV: 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/K221094
Methodology: https://510kreport.com/methodology