# K040224: Cadimplant

- Pathway: 510(k) (Traditional)
- Applicant: Praxim, Inc.
- Decided: Apr 6, 2004 after 64 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924810 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924810: Sim/Plant, Columbia Scientific, Inc. (1993) Summary page 1.

## Indications for use
CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

Source page: https://510kreport.com/device/K040224
Methodology: https://510kreport.com/methodology