# K260527: FACE4D Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Avinent Implant System S.L.U.
- Decided: Jul 2, 2026 after 135 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). 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)
- K220726: K Clear, Kline Europe GmbH (2022) Summary page 6.

## Indications for use
FACE4D aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).

Source page: https://510kreport.com/device/K260527
Methodology: https://510kreport.com/methodology