# K193385: TP Orthodontics Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Tp Orthodontics, Inc.
- Decided: Nov 12, 2020 after 342 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: 6 generations back to K780619 (1978). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163689: 3M Clear Tray Aligner, 3M Unitek Corporation (2017) Summary page 4.

## Indications for use
TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K193385
Methodology: https://510kreport.com/methodology