# K122467: 3M True Definition Scanner

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 20, 2012 after 99 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.
No later device cites it as a predicate yet.
0 of 4 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 2.
- K081961: 3M Unitek Lava Chairside Oral Scanner, Brontes Technologies (2008) Summary page 2.

## Indications for use
3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate). The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth. It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Source page: https://510kreport.com/device/K122467
Methodology: https://510kreport.com/methodology