# K172821: Ti-one 101 TS Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hung Chun Bio-S Co., Ltd.
- Decided: Jun 11, 2018 after 266 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: 12 generations back to K894595 (1990). 153 ancestors in all.
No later device cites it as a predicate yet.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110425: HC-Bios Dental Implant, Hung Chun Bio-S Co., Ltd. (2012) Summary page 4.
- K051636: Camlog Dental Implant Abutments, Healing Caps, and Accessories, Altatec GmbH (2006) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.

## Indications for use
This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore 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 I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Intended for delayed loading.

Source page: https://510kreport.com/device/K172821
Methodology: https://510kreport.com/methodology