# K013494: 3.75MM and 5.0MM Spline Twist Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Jan 18, 2002 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
Longest line of descent: 3 generations back to K894595 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K002374: Iti Dental Implant System Monotype Implant, Straumann USA (2000) Summary page 1.

## Indications for use
The Spline Twist implants are intended for surgical implantation in edentulous or partially 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 freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Source page: https://510kreport.com/device/K013494
Methodology: https://510kreport.com/methodology