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)— 510(k) K230237
Substantially EquivalentHkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
FDA 510(k) clearance K230237 for 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), Substantially Equivalent on 2023-09-14. Applicant: Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd..
Clearance details
- Applicant
- Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chongqing, CN
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
Source: openFDA MAUDE database, through . 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.