# K040874: Red, White & Blue

- Pathway: 510(k) (Traditional)
- Applicant: Allesee Orthodontic Appliances
- Decided: Jun 18, 2004 after 77 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
No predicates in its family tree.
68 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Align Technology, Invisalign: named in the summary without a submission number

## Most influential descendants
- K071970: Clear Image Aligner (2007), 67 descendants of its own
- K082556: Clearcorrect (2009), 64 descendants of its own
- K113618: Clearcorrect System (2012), 60 descendants of its own
- K180241: Orthocaps Twinaligner (2018), 15 descendants of its own
- K163689: 3M Clear Tray Aligner (2017), 13 descendants of its own

## Indications for use
Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to intermediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state,

Source page: https://510kreport.com/device/K040874
Methodology: https://510kreport.com/methodology