K230237
- 510(k) number
- K230237
- Device name
- 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. CN
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2023-09-14
- Date received
- 2023-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K230237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.