510(k) 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) by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. — Product Code MQC

K230237 is an FDA 510(k) premarket notification submitted by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on September 14, 2023. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.