# K180859: PYRAMIDION Dental Implants and Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Dentack Implants, Ltd.
- Decided: Dec 13, 2018 after 255 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 K930071 (1994). 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)
- K152188: QUAD Dental Implants and Prostheses, Dentack Impants, Ltd. (2016) Summary page 5.

## Indications for use
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.

Source page: https://510kreport.com/device/K180859
Methodology: https://510kreport.com/methodology