510(k) Report

FDA applicant

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

Chongqing, CN1 decision2023–20230 recalls

FDA records 1 decision for Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. (Chongqing, CN) in 2023: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hkable 3D Biologic Printing Technology…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQCMouthguard, Prescription1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230237Dental 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…Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K230237Dental 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…Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. · 2023

The one decision as Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. →