# K162853: Bonafix TWO - Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bonafix Surgical and Dental Implants
- Decided: Jul 14, 2017 after 276 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: 5 generations back to K925765 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.

## Indications for use
The Bonafix TWO Dental Implant System is indicated for delayed loading in surgical and restorative applications placement in the upper or lower jaw and to provide support for prosthetic devices such as artificial teeth with the goal of restoring the patient's chewing function.

Source page: https://510kreport.com/device/K162853
Methodology: https://510kreport.com/methodology