# K970776: Lifecore O-Ring Abutment;Lifecore Dalla Bona Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: May 27, 1997 after 84 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 K921764 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921764: Dalla Bona Ball & Sockey Attach. Snap Type Precis, Implant Support Systems, Inc. (1992) Summary page 1.
- K924190: Iss O-Ring Attachment, Implant Support Systems, Inc. (1993) Summary page 1.

## Indications for use
The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas: Support of fixed (cemented) restorations utilizing multiple abutments; Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar; Terminal or intermediate abutment support for fixed bridgework; Free standing restorations without involvement of adjacent dentition.

Source page: https://510kreport.com/device/K970776
Methodology: https://510kreport.com/methodology