# K250476: NizPlant Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Paragon Implant Mfg., LLC
- Decided: Dec 23, 2025 after 307 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: 7 generations back to K894595 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 5.

## Indications for use
NizPlant Implants are a one-piece implant or two-piece assembly for single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework for multi-unit tooth replacement. NizPlant Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<9mml) Implants: Indicated for multiple-unit restorations of partially or fully edentulous mandibles and maxillae where vertical bone volume is limited. The NizPlant Implants have a 2.SmmD internal hex within its most coronal portion for the insertion tool placement used in the full seating of the NizPlant Implant in the osteotomy. Implant placement, which is designed to receive multiple abutment variations, expands its restorative options allowing for the implant to be used for: • Support of attachment-retained overdentures • Support of screw-retained prostheses

Source page: https://510kreport.com/device/K250476
Methodology: https://510kreport.com/methodology