# K221000: ON3D

- Pathway: 510(k) (Traditional)
- Applicant: 3D Ons, Inc.
- Decided: May 23, 2022 after 49 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: 1 generation back to K110430 (2011). 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)
- K110430: Dolphin Imaging, Patterson Dental Supply, Inc. (2011) Summary page 4.

## Indications for use
ON3D is software that is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.

Source page: https://510kreport.com/device/K221000
Methodology: https://510kreport.com/methodology