# K080246: Composite Aligner Button

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Apr 11, 2008 after 71 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: 4 generations back to K780619 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.
- K072522: Thermoform Sheet Materials and Accessories, Dentsply International, Inc. (2007) Summary page 1.

## Indications for use
The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.

Source page: https://510kreport.com/device/K080246
Methodology: https://510kreport.com/methodology