# K982305: Spline Dental Implant System-Temporary Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Calcitek, Inc.
- Decided: Sep 22, 1998 after 83 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 Dental Implant System - Fixed Abutment: named in the summary without a submission number

## Indications for use
A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.

Source page: https://510kreport.com/device/K982305
Methodology: https://510kreport.com/methodology