# K955619: 5.0MM Spline Endosseous Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Calcitek, Inc.
- Decided: Mar 8, 1996 after 88 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) Calcitek's existing Spline Dental Implant System: named in the summary without a submission number

## Indications for use
For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

Source page: https://510kreport.com/device/K955619
Methodology: https://510kreport.com/methodology