# K251938: GEN5 and GEN5+ Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Implant Mfg., LLC
- Decided: Oct 30, 2025 after 128 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: 8 generations back to K894595 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts, Implant Direct Sybron Manufacturing, LLC (2020) Summary page 5.

## Most influential descendants
- K261392: TriActive Dental Implant System (2026), 0 descendants of its own

## Indications for use
GEN5 and GEN5 Implants: GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

Source page: https://510kreport.com/device/K251938
Methodology: https://510kreport.com/methodology