# K962106: Spline Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Calcitek, Inc.
- Decided: Aug 29, 1996 after 90 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Spline Dental Implant System: named in the summary without a submission number

## Most influential descendants
- K012055: 3.25MM Spline Twist Implant (2001), 1 descendant of its own
- K093164: 3.25 Spline Twist Implant, HA Coated (2009), 0 descendants of its own

## 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/K962106
Methodology: https://510kreport.com/methodology