# K122065: Digital Impression System for Orthodontic Use

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Feb 8, 2013 after 210 days
- Product code: NOF (System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations)
- Device class: 2
- Regulation: 21 CFR 872.3661
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K994172 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081961: 3M Unitek Lava Chairside Oral Scanner, Brontes Technologies (2008) Summary page 1.

## Most influential descendants
- K141611: Lythos Digital Impression System (2014), 0 descendants of its own

## Indications for use
The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

Source page: https://510kreport.com/device/K122065
Methodology: https://510kreport.com/methodology