FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
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)
K Number: K230237
·
Decision Sep 14, 2023
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
1
Review Days
227
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Basic Information
- 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)
- K Number
- K230237
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
- Date Received
- January 30, 2023
- Decision Date
- September 14, 2023
- Product Code
- MQC
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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