FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
BioRoot Flow 0.5g, BioRoot Flow 2g
K Number: K212283
·
Decision Sep 16, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
9
Review Days
57
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Basic Information
- Device Name
- BioRoot Flow 0.5g, BioRoot Flow 2g
- K Number
- K212283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Septodont
- Date Received
- July 21, 2021
- Decision Date
- September 16, 2021
- 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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