FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Bio-C Repair Ion+
K Number: K201222
·
Decision Feb 11, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
5
Review Days
281
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Basic Information
- Device Name
- Bio-C Repair Ion+
- K Number
- K201222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Angelus Industria DE Produtos Odontologicos S/A
- Date Received
- May 6, 2020
- Decision Date
- February 11, 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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