# K173938: IS-III HActive Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: May 24, 2018 after 149 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 K894595 (1990). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120503: Cmi Implant IS II Active, Neobiotech Co., Ltd. (2012) Summary page 5.
- K113554: Cmi Implant IS System, Neobiotech Co., Ltd. (2012) Summary page 4.
- K073033: Legacy Dental Implants, Implant Direct, LLC (2007) Summary page 5.
- K111364: Haptite Coating Implant System, Dentis Co., Ltd. (2012) Summary page 5.

## Indications for use
The IS-III HActive Fixture 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. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K173938
Methodology: https://510kreport.com/methodology