# K093821: FS Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Allesee Orthodontic Appliances
- Decided: Aug 27, 2010 after 256 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.
61 later devices descend from it; 1 cites it directly.
0 of 62 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
- (no number) Red, White & Blue, Allesee Orthodontic Appliances: named in the summary without a submission number

## Most influential descendants
- 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
- K192596: ULab Systems Dental Aligner Kit (2020), 8 descendants of its own
- K180346: Byte Aligner System (2019), 5 descendants of its own

## Indications for use
The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K093821
Methodology: https://510kreport.com/methodology