# K961665: O Butment ET Implant

- Pathway: 510(k) (Traditional)
- Applicant: O Co., Inc.
- Decided: Nov 15, 1996 after 199 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
The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.

Source page: https://510kreport.com/device/K961665
Methodology: https://510kreport.com/methodology