# K180107: Blue Sky Bio Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Feb 9, 2018 after 24 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.
4 later devices descend from it; 2 cite it directly.
0 of 14 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 6.

## Most influential descendants
- K223355: Tera Harz Clear (2022), 2 descendants of its own
- K251616: Clear Miracle (2025), 0 descendants of its own
- K233935: DigiLine Direct Print Aligner System (2024), 0 descendants of its own
- K240597: Tera Harz Clear (2024), 0 descendants of its own

## Indications for use
Blue Sky Bio Aligners are a series of clear, lightweight, 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, it sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K180107
Methodology: https://510kreport.com/methodology