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) (FDA 510(k) Clearance)

K230237 is an FDA 510(k) clearance for the Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76.... Classified as Mouthguard, Prescription (product code MQC).

Submitted by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on September 14, 2023 after a review of 227 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. devices