# K230242: OsteoCentric Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: OsteoCentric Technologies
- Decided: Oct 5, 2023 after 248 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: 11 generations back to K925765 (1993). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173701: Implant-One System, Implant Logistics, Inc. (2018) Summary page 5.

## Indications for use
The OsteoCentric Dental Implants are 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 OsteoCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading. The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

Source page: https://510kreport.com/device/K230242
Methodology: https://510kreport.com/methodology