# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd.
- Decided: Sep 14, 2023 after 227 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K251454: Clear Aligner (SCF-3348) (2026), 0 descendants of its own

## Indications for use
The Dental Braces are indicated for the fabrication of orthodontic and dental appliances, such as Orthodontic Appliances, Orthodontic Retainers, Mouth Guards and Splints.

Source page: https://510kreport.com/device/K230237
Methodology: https://510kreport.com/methodology