# K081806: Idi Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Idi Biomedical, LLC
- Decided: Nov 7, 2008 after 134 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: 9 generations back to K894595 (1990). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073142: Nobelreplace Hexagonal Implant, Nobel Biocare USA, LLC (2008) Summary page 1.

## Most influential descendants
- K101755: Aidi Dental Implant System (2010), 1 descendant of its own
- K123861: Aidi Dental Implant System (2013), 0 descendants of its own

## Indications for use
IDI Implant System 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 loading when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K081806
Methodology: https://510kreport.com/methodology