# K923889: O Butment ES Implant

- Pathway: 510(k) (Traditional)
- Applicant: O Co., Inc.
- Decided: Aug 29, 1994 after 755 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
No predicates in its family tree.
3 later devices descend from it; 3 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973926: O Butment HS Implant (1998), 1 descendant of its own
- K961665: O Butment ET Implant (1996), 1 descendant of its own
- K011574: Uniplant Dental Implant System (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K923889
Methodology: https://510kreport.com/methodology