FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K Number: K212765
·
Decision Nov 15, 2021
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
2
Review Days
76
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Basic Information
- Device Name
- Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K Number
- K212765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bloomden Bioceramics (HuNan) Co., Ltd.
- Date Received
- August 31, 2021
- Decision Date
- November 15, 2021
- 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 Bloomden Bioceramics (HuNan) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Mar 30, 2026 | Substantially Equivalent |