# K110425: HC-Bios Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hung Chun Bio-S Co., Ltd.
- Decided: Jul 27, 2012 after 529 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 K041368 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K172821: Ti-one 101 TS Dental Implant System (2018), 0 descendants of its own

## Indications for use
The HC-Bios Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type 1, 1I or mI bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Source page: https://510kreport.com/device/K110425
Methodology: https://510kreport.com/methodology