# K212772: Precision Align

- Pathway: 510(k) (Traditional)
- Applicant: Precision Align, LLC
- Decided: Jan 15, 2022 after 137 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: 2 generations back to K173784 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211010: Illusion Aligners, Laxmi Dental Exports Pvt, Ltd. (2021) Summary page 4.

## Indications for use
The Precision Align aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Precision Align aligners positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K212772
Methodology: https://510kreport.com/methodology