# K081961: 3M Unitek Lava Chairside Oral Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Brontes Technologies
- Decided: Sep 5, 2008 after 58 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: 2 generations back to K994172 (2000). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073199: 3M Espe Lava Chairside Oral Scanner, Brontes Technologies (2007) Summary page 1.

## Most influential descendants
- K122065: Digital Impression System for Orthodontic Use (2013), 1 descendant of its own
- K141611: Lythos Digital Impression System (2014), 0 descendants of its own
- K122467: 3M True Definition Scanner (2012), 0 descendants of its own

## Indications for use
The 3M Unitek Lava Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M Unitek Lava Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.

Source page: https://510kreport.com/device/K081961
Methodology: https://510kreport.com/methodology