# K012055: 3.25MM Spline Twist Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Sep 6, 2001 after 66 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: 1 generation back to K944327 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944327: Integral VI Biointegrated Dental Implant System, Calcitek, Inc. (1995) Summary page 2.
- K946311: Integral Vii 3.25MM Biointegrated Dental Implant System, Calcitek, Inc. (1995) Summary page 2.
- K962106: Spline Dental Implant Systems, Calcitek, Inc. (1996) Summary page 2.

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

## Indications for use
Sulzer Dental Implant Systems are designed 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. 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. The 3.15mm implant is recommended for the anterior mandible and the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

Source page: https://510kreport.com/device/K012055
Methodology: https://510kreport.com/methodology