# K252870: Invisalign Specifix Attachment System

- Pathway: 510(k) (Special)
- Applicant: Align Technology, Inc.
- Decided: Oct 9, 2025 after 30 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: 7 generations back to K780619 (1978). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222894: Invisalign System, Pre-Formed Attachment System, Align Technology, Inc. (2022) Summary page 5.

## Indications for use
Invisalign Specifix Attachment System is a directly fabricated accessory indicated to bond attachments and/or engagement features to apply force for tooth movement during orthodontic treatment of malocclusion, and/or for retention of Align orthodontic appliances.

Source page: https://510kreport.com/device/K252870
Methodology: https://510kreport.com/methodology