# K251454: Clear Aligner (SCF-3348)

- Pathway: 510(k) (Traditional)
- Applicant: Beame Medical Technology (Shenzhen) Limited
- Decided: Jan 7, 2026 after 240 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: 8 generations back to K780619 (1978). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233356: Illusion Aligner Pro: Illusion Aligner FLX, Laxmi Dental Export Pvt., Ltd. (2024) Summary page 6.
- K230237: Dental Braces (Model:  HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0), Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. (2023) Summary page 6.

## Indications for use
Clear Aligner is indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion.

Source page: https://510kreport.com/device/K251454
Methodology: https://510kreport.com/methodology