# K053010: Vistadent at Complete, Model 3.1

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Nov 22, 2005 after 27 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930527 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043104: Kodak Orthodontic Imaging and Oms Imaging 8.0, Practiceworks, Inc. (2005) Summary page 1.
- K982422: Eaglesoft Chairside, Eaglesoft, A Patterson Co. (1998) Summary page 1.
- K012439: Dentaleye 2 Dental Image Management System, Radco Data AB (2002) Summary page 1.

## Most influential descendants
- K213263: OnyxCeph (2023), 0 descendants of its own

## Indications for use
VISTADENT m AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

Source page: https://510kreport.com/device/K053010
Methodology: https://510kreport.com/methodology