# K042339: Neoplant Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Nov 2, 2004 after 64 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: 1 generation back to K874590 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K950204: 3I Standard Threaded/Self-Tapping Threaded Implants, Miniplants (TM), Implant Innovations, Inc. (1995) Summary page 1.
- K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants, Implant Innovations, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K086063: 3i Dental Implants. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
NEOPLANT Internal Hex Implant system is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Source page: https://510kreport.com/device/K042339
Methodology: https://510kreport.com/methodology