FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FiteBac CC OrthoSeal
K Number: K210115
·
Decision Jul 29, 2021
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
191
Applicant Total
3
Review Days
191
Basic Information
- Device Name
- FiteBac CC OrthoSeal
- K Number
- K210115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Largent Health, LLC
- Date Received
- January 19, 2021
- Decision Date
- July 29, 2021
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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