# K123925: MTM Clear Aligner in-Office

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: May 24, 2013 after 155 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: 3 generations back to K780619 (1978). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K081960: Invisalign System, Align Technology (2008) Summary page 1.
- K981095: Align System, Align Technology (1998) Summary page 4.

## Most influential descendants
- K132145: MTM (R) Clear Aligner (2013), 1 descendant of its own
- K163155: MTM Clear Aligner (2017), 0 descendants of its own

## Indications for use
MTM@D Clear Aligner In-Office is indicated for the treatment of anterior toot malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation, and bodily movement), MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K123925
Methodology: https://510kreport.com/methodology