# K173701: Implant-One System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Logistics, Inc.
- Decided: Nov 29, 2018 after 360 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: 10 generations back to K925765 (1993). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102822: Implant-One System, Custom Dental Implants, Inc. (2011) Summary page 4.

## Most influential descendants
- K230242: OsteoCentric Dental Implant System (2023), 0 descendants of its own

## Indications for use
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient’s chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Source page: https://510kreport.com/device/K173701
Methodology: https://510kreport.com/methodology