K230237

Substantially Equivalent

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)

Applicant: Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Product code: MQC
Advisory panel: Unknown
Date received: 2023-01-30
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.