# K152188: QUAD Dental Implants and Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Dentack Impants, Ltd.
- Decided: Jan 28, 2016 after 176 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: 2 generations back to K930071 (1994). 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)
- K981141: Sargon Immediate Load Implant, Model D, Sargon Ent., Inc. (1999) Summary page 5.

## Most influential descendants
- K180859: PYRAMIDION Dental Implants and Prostheses (2018), 0 descendants of its own

## Indications for use
DenTack QUAD 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 delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K152188
Methodology: https://510kreport.com/methodology