# K132145: MTM (R) Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Oct 11, 2013 after 92 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: 4 generations back to K780619 (1978). 4 ancestors in all.
1 later device descends 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)
- K123925: MTM Clear Aligner in-Office, Dentsply International, Inc. (2013) Summary page 1.

## Most influential descendants
- K163155: MTM Clear Aligner (2017), 0 descendants of its own

## Indications for use
MTM® Clear-Aligner is indicated for the treatment of anterior tooth 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/K132145
Methodology: https://510kreport.com/methodology