# K163155: MTM Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Feb 3, 2017 after 85 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132145: MTM (R) Clear Aligner, Dentsply International, Inc. (2013) Summary page 4.
- K123514: Clearpath Aligner, Qserve America, Inc. (2013) Summary page 4.

## 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, MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K163155
Methodology: https://510kreport.com/methodology