# K101755: Aidi Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Aidi Biomedical, LLC
- Decided: Nov 22, 2010 after 152 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 K894595 (1990). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.
- K081806: Idi Implant System, Idi Biomedical, LLC (2008) Summary page 2.

## Most influential descendants
- K123861: Aidi Dental Implant System (2013), 0 descendants of its own

## Indications for use
AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches 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 placement and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K101755
Methodology: https://510kreport.com/methodology