# K162299: Spiral Shape Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Gp Implants
- Decided: Jun 22, 2017 after 310 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: 10 generations back to K960026 (1996). 76 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 4.

## Most influential descendants
- K191443: MSDI Dental Implants System (2020), 1 descendant of its own
- K213677: Bonafix 2 Plus (2022), 0 descendants of its own
- K172240: SPI Dental Implant System (2018), 0 descendants of its own

## Indications for use
The Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K162299
Methodology: https://510kreport.com/methodology