# K093164: 3.25 Spline Twist Implant, HA Coated

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Dec 15, 2009 after 70 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944327 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
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 1.
- K012055: 3.25MM Spline Twist Implant, Sulzer Dental, Inc. (2001) Summary page 1.

## Recalls of this device
- Oct 1, 2014 · Class II · Z-0153-2015: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

## Indications for use
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K093164
Methodology: https://510kreport.com/methodology