# K162482: A.B. DENTAL DEVICES Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Device, Ltd.
- Decided: Sep 15, 2017 after 374 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: 15 generations back to K960026 (1996). 248 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132125: A.B. Dental Devices Dental Implants System, A.B. Dental Devices, Ltd. (2014) Summary page 4.

## Most influential descendants
- K220022: TRATE Dental Implant System (2022), 1 descendant of its own
- K232383: iPhysio® System (2025), 0 descendants of its own
- K182455: A.B. DENTAL DEVICES Dental Implants System (2019), 0 descendants of its own
- K181381: A.B. Dental Devices Dental Implants System (2018), 0 descendants of its own

## Indications for use
A.B. DENTAL DEVICES® Dental Implants 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. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: I22, I5, I55, I10. P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.

Source page: https://510kreport.com/device/K162482
Methodology: https://510kreport.com/methodology