# K210610: PrimeTaper EV Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Aug 27, 2021 after 179 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: 12 generations back to K894595 (1990). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 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 4.

## 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 implant shorter than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Source page: https://510kreport.com/device/K210610
Methodology: https://510kreport.com/methodology