# K202092: ABC Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Abracadabra Implants, Ltd.
- Decided: Sep 23, 2021 after 422 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.
No later device cites it as a predicate yet.
0 of 77 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.

## Indications for use
The ABC 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. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K202092
Methodology: https://510kreport.com/methodology