# K240966: Prima Plus Conical Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Dental, Inc.
- Decided: Jul 9, 2024 after 91 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 K960026 (1996). 124 ancestors in all.
No later device cites it as a predicate yet.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223814: Genesis ACTIVE Implant System, Keystone Dental, Inc. (2023) Summary page 5.

## Indications for use
The Prima PlusTM Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus TM Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima PlusTM Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Prima Plus TM Conical Implant System implants are to be sent to a Keystone Dental validated milling center for manufacture.

Source page: https://510kreport.com/device/K240966
Methodology: https://510kreport.com/methodology