# K220022: TRATE Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Trate AG
- Decided: Apr 4, 2022 after 89 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: 16 generations back to K960026 (1996). 249 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162482: A.B. DENTAL DEVICES Dental Implants System, A.B. Dental Device, Ltd. (2017) Summary page 4.

## Most influential descendants
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
TRATE 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. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K220022
Methodology: https://510kreport.com/methodology