FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
K Number: K240304
·
Decision May 28, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
2
Review Days
116
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Basic Information
- Device Name
- Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
- K Number
- K240304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Enpuno Biotechnology Co., Ltd.
- Date Received
- February 2, 2024
- Decision Date
- May 28, 2024
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Enpuno Biotechnology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251465 | Root canal repair materials (nRoot BP) | Sep 25, 2025 | Substantially Equivalent |