# K141611: Lythos Digital Impression System

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Dec 5, 2014 after 172 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: 4 generations back to K994172 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122065: Digital Impression System for Orthodontic Use, Ormco Corp. (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K141611
Methodology: https://510kreport.com/methodology