# K251758: Serafin®

- Pathway: 510(k) (Traditional)
- Applicant: Tns Co., Ltd.
- Decided: Sep 11, 2025 after 94 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)
- K232074: Serafin®, Tns Co., Ltd. (2024) Summary page 5.
- K220287: Invisalign System, Align Technology, Inc. (2022) Summary page 5.

## Indications for use
The Serafin is intended for the orthodontic treatment of malocclusion in patients with mixed and permanent dentition.

Source page: https://510kreport.com/device/K251758
Methodology: https://510kreport.com/methodology