# K984536: Removable Cuff Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Calcitek, Inc.
- Decided: Jun 16, 1999 after 177 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Spline Abutments: named in the summary without a submission number
- (no number) Omniloc Abutments: Fixed, 15 and 25 degree pre-angled: named in the summary without a submission number

## Indications for use
They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.

Source page: https://510kreport.com/device/K984536
Methodology: https://510kreport.com/methodology