# K151965: Dentti System

- Pathway: 510(k) (Traditional)
- Applicant: Martz, Inc.
- Decided: Mar 11, 2016 after 239 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K780619 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081960: Invisalign System, Align Technology (2008) Summary page 4.
- K071970: Clear Image Aligner, Specialty Appliance Works, Inc. (2007) Summary page 4.
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 4.

## Indications for use
“The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.”

Source page: https://510kreport.com/device/K151965
Methodology: https://510kreport.com/methodology