# K962576: Spline X Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Calcitek, Inc.
- Decided: Feb 10, 1997 after 224 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.
95 later devices descend from it; 1 cites it directly.
0 of 96 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
- K101880: Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant (2010), 94 descendants of its own
- K112160: Tapered Screw-Vent X Implant (2011), 88 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 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/K962576
Methodology: https://510kreport.com/methodology