510(k) 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) by
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
— Product Code MQC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2023
- Date Received
- January 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type