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)

• K Number: K230237
• Device Name: 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)
• Manufacturer: Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
• Date Cleared: 2023-09-14 ( 227 days)
• Product Code: MQC , KMY
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for dental braces, which are physical medical devices, not an AI/ML device. The document describes traditional regulatory clearance based on substantial equivalence to a predicate device, rather than performance criteria for an AI/ML diagnostic or assistive tool.

Therefore, the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set size is not applicable to this document. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices.

Regulation Number and Section

N/A