# K050408: Bicon Orthodontic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Apr 7, 2005 after 49 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The device is a temporary device that is screwed into the jawbone that will be removed after completion of treatment.

Source page: https://510kreport.com/device/K050408
Methodology: https://510kreport.com/methodology