# K123861: Aidi Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Aidi Biomedical, LLC
- Decided: Dec 12, 2013 after 363 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: 11 generations back to K894595 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101755: Aidi Dental Implant System, Aidi Biomedical, LLC (2010) Summary page 1.
- K081806: Idi Implant System, Idi Biomedical, LLC (2008) Summary page 1.

## Indications for use
The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.

Source page: https://510kreport.com/device/K123861
Methodology: https://510kreport.com/methodology