# K252145: GEN5™ and GEN5+™ 3.3mmD Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Implant Mfg., LLC
- Decided: Dec 23, 2025 after 167 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.
No later device cites it as a predicate yet.
0 of 21 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.

## Indications for use
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. • Narrow GEN5 Implants (3.3mmD), are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization.

Source page: https://510kreport.com/device/K252145
Methodology: https://510kreport.com/methodology