# K973926: O Butment HS Implant

- Pathway: 510(k) (Traditional)
- Applicant: O Co., Inc.
- Decided: Jan 5, 1998 after 82 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 K900179 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923889: O Butment ES Implant, O Co., Inc. (1994) Summary page 1.
- K900179: Screw-Vent Endosseous Implant Abutments, Core-Vent Corp. (1991) Summary page 1.

## Most influential descendants
- K011574: Uniplant Dental Implant System (2001), 0 descendants of its own

## Indications for use
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

Source page: https://510kreport.com/device/K973926
Methodology: https://510kreport.com/methodology