# K073121: Nubrace Invisible Removable Orthodontics

- Pathway: 510(k) (Traditional)
- Applicant: Nubrace, Inc.
- Decided: Feb 12, 2009 after 465 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 K780619 (1978). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981095: Align System, Align Technology (1998) Summary page 1.

## Most influential descendants
- K123514: Clearpath Aligner (2013), 6 descendants of its own
- K162609: ClearPath Aligner (2017), 4 descendants of its own
- K202857: ClearPath Aligner (2021), 3 descendants of its own
- K221097: SmileSeries (2022), 1 descendant of its own
- K241137: Clear Moves Aligner (2024), 0 descendants of its own

## Indications for use
The NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K073121
Methodology: https://510kreport.com/methodology