FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Apapro Desensitizer
K Number: K220419
·
Decision Feb 16, 2022
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
2
Review Days
2
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Basic Information
- Device Name
- Apapro Desensitizer
- K Number
- K220419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sangi Co., Ltd.
- Date Received
- February 14, 2022
- Decision Date
- February 16, 2022
- Product Code
- LBH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
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Other Clearances by Sangi Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Mar 18, 2026 | Substantially Equivalent |