Cleared Traditional

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 · Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. · Dental device

Sep 2023

Decision

227d

Days

Risk

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, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0). This device is classified as a Mouthguard, Prescription.

Submitted by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on September 14, 2023, 227 days after receiving the submission on January 30, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K230237 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 2023
Decision Date	September 14, 2023
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement