FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dental Glass Ceramics Blocks (HT, LT, MT)
K Number: K242407
·
Decision Nov 13, 2024
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
2
Review Days
91
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Basic Information
- Device Name
- Dental Glass Ceramics Blocks (HT, LT, MT)
- K Number
- K242407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hunan Vsmile Biotechnology Co., Ltd.
- Date Received
- August 14, 2024
- Decision Date
- November 13, 2024
- Product Code
- EIH
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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Other Clearances by Hunan Vsmile Biotechnology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Jul 29, 2022 | Substantially Equivalent |