# K990277: O-Ring Abutment

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Apr 9, 1999 after 71 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lifecore Biomedical O-Ring Abutment System: named in the summary without a submission number
- (no number) SteriOss O-Ring Abutment System: named in the summary without a submission number
- (no number) Implant Innovations O-Ring Abutment System: named in the summary without a submission number

## Most influential descendants
- K093975: Simpler Toadstool Abutment, Model S19000-S19009 (2010), 0 descendants of its own

## Indications for use
The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.

Source page: https://510kreport.com/device/K990277
Methodology: https://510kreport.com/methodology